Colorectal Neuroendocrine Tumor G1, Gastric Neuroendocrine Tumor G1, Neuroendocrine Neoplasm, Neuroendocrine Tumor, Neuroendocrine Tumor G2
Conditions
Brief summary
This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.
Detailed description
PRIMARY OBJECTIVES: I. To compare central review-based progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide (octreotide acetate) plus bevacizumab, or depot octreotide plus interferon (recombinant interferon alfa-2b). SECONDARY OBJECTIVES: I. To compare overall survival, time to treatment failure and traditionally reported progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. II. To compare objective response (confirmed and unconfirmed complete response \[CR\] and partial response \[PR\]) in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. III. To compare the toxicity profile of patients treated with these two regimens. TERTIARY OBJECTIVES: I. To assess the prognostic and predictive value of vascular endothelial growth factor (VEGF) expression in relation to progression-free survival and treatment effect. II. To compare response of 5HIAA, chromogranin A and neuronspecific enolase among patients with elevated levels at baseline between patients treated with octreotide plus interferon versus octreotide plus bevacizumab. III. To assess and compare the prognostic and predictive value of the combination of In-111 pentetreotide somatostatin-receptor scintigraphy (SRS) and computed tomography (CT) vs. CT in relation to progression-free survival (PFS). IV. To assess and compare the prognostic and predictive value of the combination of SRS and CT vs. CT in relation to overall survival (OS) and time to treatment failure (TTF). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive octreotide acetate intramuscularly (IM) and bevacizumab intravenously (IV) over 30-90 minutes on day 1. ARM II: Patients receive octreotide acetate IM on day 1 and recombinant interferon alfa-2b subcutaneously (SC) on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment in both arms repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-6 months for up to 3 years.
Interventions
Given IV
Correlative studies
Given IM
Given SC
Sponsors
Study design
Eligibility
Inclusion criteria
* Patient must have unresectable metastatic or locally advanced, low- or intermediate-grade neuroendocrine carcinoma * NOTE: pathology report must state one of the following: carcinoid, low-grade or well-differentiated neuroendocrine carcinoma, atypical carcinoid, intermediate-grade or moderately differentiated neuroendocrine carcinoma; patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, or goblet cell carcinoid are not eligible; patient must not have osseous metastasis as only site of disease; patients with medullary thyroid carcinoma or islet cell carcinoma are not eligible; if pathology report states only neuroendocrine carcinoma, pathology subtype must be reconfirmed * Occasionally, it is not possible to establish tumor grade on fine-needle aspiration (FNA) cytology material; if a new biopsy is needed, a core needle biopsy should be obtained whenever possible * Patient must have high risk disease as defined by at least one of the following: * Progressive disease * Refractory carcinoid syndrome while receiving octreotide (defined by \> 2 flushing episodes/day or \> 4 bowel movements/day) * Atypical histology and more than 6 lesions * Metastatic colorectal carcinoid; patients with metastatic cecal or appendiceal carcinoid tumor are not eligible unless the tumors fit into one of the other high-risk categories (a, b, or c above) * Metastatic gastric carcinoid * Patient must have measurable disease; CT or magnetic resonance imaging (MRI) used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form; these scans also must be submitted for central radiology review * Institutions are required to submit CT/MRI scans and archived tissue for pathology review; furthermore, institutions are required to seek additional patient consent for submission of octreotide scans, and submission of blood and use of archived tissue for correlative studies * If patient consents to the submission of octreotide scans, the patient must also be registered to Registration Step 2 * Patient may have had up to one prior regimen of cytotoxic chemotherapy; at least 28 days must have elapsed since completion of prior therapy, and patient must have recovered from all effects * Patient may have had prior hepatic artery embolization; at least 28 days must have elapsed since embolization and there must be residual measurable disease; chemoembolization will be considered as one prior chemotherapy regimen * Patient must not have received prior interferon, bevacizumab or any other therapy targeting VEGF or VEGF receptors * Patient may have received prior therapy targeting stem cell factor receptor (c-kit), abelson murine leukemia viral oncogene homolog 1 (abl), platelet-derived growth factor receptor (PDGFR), mammalian target of rapamycin (mTOR), and somatostatin receptors (not counted toward prior cytotoxic chemotherapy) * Prior radiation is allowed; there must be measurable disease; if prior therapies include peptide receptor radiotherapy, the target lesion(s) must have shown disease progression; at least 28 days must have elapsed since completion of prior therapy, and patient must have recovered from all effects * Patients must have recovered from any prior surgery; one week must have elapsed from the time of a minor surgery and 4 weeks from major surgery * At least 21 days must have elapsed since any prior octreotide LAR depot treatment * Patient must have a Zubrod performance status of 0-2 * Absolute neutrophil count (ANC) \> 1,500/mcl * Hemoglobin \> 8 g/dl * Platelets \> 100,000/mcl * Serum bilirubin \< 1.5 x institutional upper limit of normal (IULN) * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x IULN * Serum creatinine \< 1.5 mg/dL * Urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio \> 0.5, 24-hour urine protein must be obtained and the level must be \< 1,000 mg for patient enrollment; these results must be obtained within 28 days prior to registration * Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion - a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm * Patients not on anticoagulation must have prothrombin time (PT) and partial thromboplastin time (PTT) =\< 1.1 x lULN obtained within 28 days prior to registration; patients on full-dose anticoagulation (warfarin or low molecular weight heparin) are eligible provided that both of the following criteria are met: * The patient has an in-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin * The patient has no active bleeding or pathological condition that carries a high risk of bleeding such as varices * Patient must not have history or evidence of clinically significant peripheral vascular disease such as non-healing peripheral ulcers or claudication * Patient must not have a history of primary brain tumor or metastatic cancer to the brain; brain imaging studies are not required for eligibility if the patient has no neurological signs or symptoms; if brain imaging studies are performed, they must be negative for disease * Patient must not have a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration * Patient must not have history within the past 5 years or presence of bleeding diathesis or coagulopathy that results in spontaneous bleeding (in the absence of trauma) requiring packed red blood cells (pRBC) transfusion * Patient must not have a serious (requiring active medical therapy with medication or medical device under the supervision of a physician) non-healing wound, ulcer, or bone fracture * Patient must not have recent history (within 6 months prior to registration) of these arterial thromboembolic events: transient ischemic attack, cerebrovascular accident, unstable angina, myocardial infarction, or New York Heart Association grade II or higher congestive heart failure * Patients with a history of hypertension must be well-controlled (blood pressure \< 150/90), on a stable regimen of antihypertensive therapy * Patient must not have hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia * Patient must not plan to use any other concurrent chemotherapy, immunotherapy, hepatic artery embolization, hepatic artery chemoembolization, radiofrequency ablation, other tumor ablative procedure or radiotherapy while on protocol treatment * Patient must not be pregnant or nursing because bevacizumab may be harmful to the developing fetus and newborn; male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout protocol treatment and for up to 6 months following discontinuation of bevacizumab * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any other cancer from which the patient has been disease free for five years * All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional re view board approval for this study has been entered into the data base * REGISTRATION STEP 2 - SPECT SUBSTUDY * Patient must have registered to the main study * Patient must have consented to the submission of octreotide scans * An octreotide scan obtained within 28 days prior to Registration Step 1 must be available for submission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Review-based Progression-Free Survival | Up to 3 years | From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 7 years | From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. |
| Time to Treatment Failure | Up to 3 years | From date of randomization (which is the date of registration) to date of first observation of progressive disease (as defined in Section 10.2d), death due to any cause, symptomatic deterioration (as defined in Section 10.2e), or discontinuation of treatment. This has been calculated using Central-Review based progression events. Patients last known not to have failed treatment are censored at date last known not to have failed. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not failed treatment prior to that time. |
| Local Progression-Free Survival (Investigator Assessed) | Up to 3 years | From date of randomization (which is the date of registration) to date of first documentation of progression \[per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as defined in Section 10.2d\] or symptomatic deterioration (as defined in Section 10.2e), or death due to any cause. Patients last known not to have progressed are censored at date of last contact. Progression (Section 10.2d) includes one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over smallest sum observed using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of new lesion/site; or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration (Section 10.2e) is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. |
| Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Up to 3 years | Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is disappearance of all measurable and non-measurable disease, and no new lesions; Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR. |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Up to 3 years | Only adverse events that are possibly, probably or definitely related to study drug are reported. |
Countries
United States
Contacts
SWOG Cancer Research Network
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Octreotide, Bevacizumab Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. | 200 |
| Octreotide, Interferon Alpha-2b Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. | 202 |
| Total | 402 |
Baseline characteristics
| Characteristic | Octreotide, Interferon Alpha-2b | Total | Octreotide, Bevacizumab |
|---|---|---|---|
| Age, Continuous | 61.1 years | 60.9 years | 60.5 years |
| Disease Site Other sites | 130 participants | 259 participants | 129 participants |
| Disease Site Small bowel, cecum, appendix | 72 participants | 143 participants | 71 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 24 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 177 Participants | 343 Participants | 166 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 35 Participants | 21 Participants |
| Histologic Grade Intermediate (atypical) | 31 participants | 62 participants | 31 participants |
| Histologic Grade Low | 171 participants | 340 participants | 169 participants |
| Prior Octreotide None within 2 months prior to registration | 87 participants | 173 participants | 86 participants |
| Prior Octreotide Within 2 months prior to registration | 115 participants | 229 participants | 114 participants |
| Progression after Initial Diagnosis No | 14 participants | 32 participants | 18 participants |
| Progression after Initial Diagnosis Yes | 188 participants | 370 participants | 182 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 38 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 14 Participants | 3 Participants |
| Race (NIH/OMB) White | 167 Participants | 336 Participants | 169 Participants |
| Sex: Female, Male Female | 112 Participants | 210 Participants | 98 Participants |
| Sex: Female, Male Male | 90 Participants | 192 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 103 / 197 | 98 / 194 |
| serious Total, serious adverse events | 68 / 197 | 9 / 194 |
Outcome results
Central Review-based Progression-Free Survival
From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiological Review date, unless subsequent scans or documentation of symptomatic deterioration provides evidence of progression. Patients last known not to have progressed are censored at the date of last contact. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not progressed prior to that time.
Time frame: Up to 3 years
Population: According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octreotide, Bevacizumab | Central Review-based Progression-Free Survival | 16.6 months |
| Octreotide, Interferon Alpha-2b | Central Review-based Progression-Free Survival | 15.4 months |
Local Progression-Free Survival (Investigator Assessed)
From date of randomization (which is the date of registration) to date of first documentation of progression \[per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as defined in Section 10.2d\] or symptomatic deterioration (as defined in Section 10.2e), or death due to any cause. Patients last known not to have progressed are censored at date of last contact. Progression (Section 10.2d) includes one or more of the following: 20% increase in the sum of the longest diameters of target measurable lesions over smallest sum observed using the same techniques as baseline; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of new lesion/site; or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration (Section 10.2e) is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time frame: Up to 3 years
Population: According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octreotide, Bevacizumab | Local Progression-Free Survival (Investigator Assessed) | 15.4 months |
| Octreotide, Interferon Alpha-2b | Local Progression-Free Survival (Investigator Assessed) | 10.6 months |
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to 3 years
Population: Eligible patients who received any treatment and were assessed for adverse events are included in this summary. Eleven patients did not start protocol treatment due to: patient refusal (6), financial reasons (3), and worsening condition/progression (2). None were assessable for adverse events and thus are not included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fistula, GI - Colon/cecum/appendix | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction/hypersensitivity | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ataxia (incoordination) | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Auditory/Ear-Other (Specify) | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | CNS cerebrovascular ischemia | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiac troponin I (cTnI) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiac-ischemia/infarction | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiopulmonary arrest, cause unknown (non-fatal) | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cholecystitis | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cognitive disturbance | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Creatinine | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 3 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dental: periodontal disease | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 7 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema: limb | 4 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 13 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fistula, GU - Vagina | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hearing: pts w/o audiogram not enroll monitor prgm | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Heartburn/dyspepsia | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Rectum | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Upper GI NOS | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage/Bleeding-Other (Specify) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hot flashes/flushes | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hydrocephalus | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 62 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | INR (of prothrombin time) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ileus, GI (functional obstruction of bowel) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Nose | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Scrotum | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Urinary tract NOS | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lipase | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 3 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mental status | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 5 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Obstruction, GI - Gallbladder | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Obstruction, GI - Small bowel NOS | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 7 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Back | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest wall | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Esophagus | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Gallbladder | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 9 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Liver | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Stomach | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-Other (Specify) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 3 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Proteinuria | 17 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Renal failure | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Renal/Genitourinary-Other (Specify) | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Seizure | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Somnolence/depressed level of consciousness | 3 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 2 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/embolism (vascular access-related) | 3 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 3 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Triglyceride, serum-high (hypertriglyceridemia) | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ulcer, GI - Duodenum | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ulcer, GI - Stomach | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vasculitis | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vessel injury-artery - Aorta | 1 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vision-blurred vision | 0 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 4 Participants |
| Octreotide, Bevacizumab | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 2 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Muscle | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | ALT, SGPT (serum glutamic pyruvic transaminase) | 4 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Left ventricular systolic dysfunction | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | AST, SGOT | 6 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ulcer, GI - Stomach | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Albumin, serum-low (hypoalbuminemia) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Leukocytes (total WBC) | 14 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Alkaline phosphatase | 6 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Stomach | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Allergic reaction/hypersensitivity | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lipase | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Anorexia | 8 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Somnolence/depressed level of consciousness | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ataxia (incoordination) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Lymphopenia | 5 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Auditory/Ear-Other (Specify) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain-Other (Specify) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Bilirubin (hyperbilirubinemia) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mental status | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | CNS cerebrovascular ischemia | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vomiting | 2 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiac troponin I (cTnI) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - agitation | 2 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiac-ischemia/infarction | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Phosphate, serum-low (hypophosphatemia) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cardiopulmonary arrest, cause unknown (non-fatal) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - anxiety | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cholecystitis | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Syncope (fainting) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Cognitive disturbance | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mood alteration - depression | 7 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Colitis | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Platelets | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Constipation | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (clinical exam) - Oral cavity | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Creatinine | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Uric acid, serum-high (hyperuricemia) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dehydration | 5 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Mucositis/stomatitis (functional/symp) - Oral cav | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dental: periodontal disease | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pneumonitis/pulmonary infiltrates | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Diarrhea | 9 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Muscle weakness, not d/t neuropathy - body/general | 3 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dizziness | 3 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/embolism (vascular access-related) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Dyspnea (shortness of breath) | 2 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Nausea | 9 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Edema: limb | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Potassium, serum-low (hypokalemia) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fatigue (asthenia, lethargy, malaise) | 50 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neuropathy: motor | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fever in absence of neutropenia, ANC lt1.0x10e9/L | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vision-blurred vision | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fistula, GI - Colon/cecum/appendix | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Neutrophils/granulocytes (ANC/AGC) | 23 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Fistula, GU - Vagina | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Proteinuria | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Glucose, serum-high (hyperglycemia) | 5 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Obstruction, GI - Gallbladder | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hearing: pts w/o audiogram not enroll monitor prgm | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Thrombosis/thrombus/embolism | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Heartburn/dyspepsia | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Obstruction, GI - Small bowel NOS | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemoglobin | 4 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pruritus/itching | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, CNS | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Abdomen NOS | 5 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Rectum | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vasculitis | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, GI - Upper GI NOS | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Back | 2 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage, pulmonary/upper respiratory - Nose | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Rash/desquamation | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hemorrhage/Bleeding-Other (Specify) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Bone | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hot flashes/flushes | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Triglyceride, serum-high (hypertriglyceridemia) | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hydrocephalus | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest wall | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypertension | 4 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Renal failure | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypotension | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Chest/thorax NOS | 2 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Hypoxia | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Weight loss | 3 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | INR (of prothrombin time) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Esophagus | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ileus, GI (functional obstruction of bowel) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Renal/Genitourinary-Other (Specify) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Blood | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Extremity-limb | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Lung | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Ulcer, GI - Duodenum | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf (clin/microbio) w/Gr 3-4 neuts - Nose | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Gallbladder | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Ab NOS | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Seizure | 2 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - Lung | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Head/headache | 3 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Inf w/normal ANC or Gr 1-2 neutrophils - UTI | 2 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Vessel injury-artery - Aorta | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Scrotum | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Pain - Liver | 1 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Infection with unknown ANC - Urinary tract NOS | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Sodium, serum-low (hyponatremia) | 0 Participants |
| Octreotide, Interferon Alpha-2b | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Insomnia | 1 Participants |
Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0): Complete Response (CR) is disappearance of all measurable and non-measurable disease, and no new lesions; Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed response is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Time frame: Up to 3 years
Population: All eligible patients with measurable disease will be included in this analysis according to the randomized treatment assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Octreotide, Bevacizumab | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Complete Response | 2 participants |
| Octreotide, Bevacizumab | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Partial Response | 20 participants |
| Octreotide, Bevacizumab | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Unconfirmed Complete Response | 0 participants |
| Octreotide, Bevacizumab | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Unconfirmed Partial Response | 7 participants |
| Octreotide, Bevacizumab | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Stable/No Resposne | 135 participants |
| Octreotide, Bevacizumab | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Increasing Disease | 20 participants |
| Octreotide, Bevacizumab | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Symptomatic Deterioration | 0 participants |
| Octreotide, Bevacizumab | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Assessment Inadequate | 16 participants |
| Octreotide, Interferon Alpha-2b | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Assessment Inadequate | 17 participants |
| Octreotide, Interferon Alpha-2b | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Complete Response | 0 participants |
| Octreotide, Interferon Alpha-2b | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Stable/No Resposne | 137 participants |
| Octreotide, Interferon Alpha-2b | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Partial Response | 8 participants |
| Octreotide, Interferon Alpha-2b | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Symptomatic Deterioration | 3 participants |
| Octreotide, Interferon Alpha-2b | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Unconfirmed Complete Response | 1 participants |
| Octreotide, Interferon Alpha-2b | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Increasing Disease | 30 participants |
| Octreotide, Interferon Alpha-2b | Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) | Unconfirmed Partial Response | 6 participants |
Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time frame: Up to 7 years
Population: According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octreotide, Bevacizumab | Overall Survival | 35.2 months |
| Octreotide, Interferon Alpha-2b | Overall Survival | 47.3 months |
Time to Treatment Failure
From date of randomization (which is the date of registration) to date of first observation of progressive disease (as defined in Section 10.2d), death due to any cause, symptomatic deterioration (as defined in Section 10.2e), or discontinuation of treatment. This has been calculated using Central-Review based progression events. Patients last known not to have failed treatment are censored at date last known not to have failed. Patients with incomplete Central Radiological Review are censored at the date of last Central Radiological Review if patient has not failed treatment prior to that time.
Time frame: Up to 3 years
Population: According to the intent-to-treat principle, all eligible patients will be included in this analysis according to the randomized treatment assignment, regardless of actual treatments received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Octreotide, Bevacizumab | Time to Treatment Failure | 9.9 months |
| Octreotide, Interferon Alpha-2b | Time to Treatment Failure | 5.6 months |