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Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00569127
Enrollment
427
Registered
2007-12-06
Start date
2007-12-01
Completion date
2027-01-31
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neuroendocrine Tumor G1, Gastric Neuroendocrine Tumor G1, Neuroendocrine Neoplasm, Neuroendocrine Tumor, Neuroendocrine Tumor G2

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

BIOLOGICALBevacizumab

Given IV

OTHERLaboratory Biomarker Analysis

Correlative studies

DRUGOctreotide Acetate

Given IM

BIOLOGICALRecombinant Interferon Alfa-2b

Given SC

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Central Review-based Progression-Free SurvivalUp to 3 yearsFrom 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

MeasureTime frameDescription
Overall SurvivalUp to 7 yearsFrom 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 FailureUp to 3 yearsFrom 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 yearsFrom 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 yearsPer 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 DrugUp to 3 yearsOnly adverse events that are possibly, probably or definitely related to study drug are reported.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJames C Yao

SWOG Cancer Research Network

Participant flow

Participants by arm

ArmCount
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
Total402

Baseline characteristics

CharacteristicOctreotide, Interferon Alpha-2bTotalOctreotide, Bevacizumab
Age, Continuous61.1 years60.9 years60.5 years
Disease Site
Other sites
130 participants259 participants129 participants
Disease Site
Small bowel, cecum, appendix
72 participants143 participants71 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants24 Participants13 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
177 Participants343 Participants166 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
14 Participants35 Participants21 Participants
Histologic Grade
Intermediate (atypical)
31 participants62 participants31 participants
Histologic Grade
Low
171 participants340 participants169 participants
Prior Octreotide
None within 2 months prior to registration
87 participants173 participants86 participants
Prior Octreotide
Within 2 months prior to registration
115 participants229 participants114 participants
Progression after Initial Diagnosis
No
14 participants32 participants18 participants
Progression after Initial Diagnosis
Yes
188 participants370 participants182 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
4 Participants6 Participants2 Participants
Race (NIH/OMB)
Black or African American
20 Participants38 Participants18 Participants
Race (NIH/OMB)
More than one race
0 Participants4 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants14 Participants3 Participants
Race (NIH/OMB)
White
167 Participants336 Participants169 Participants
Sex: Female, Male
Female
112 Participants210 Participants98 Participants
Sex: Female, Male
Male
90 Participants192 Participants102 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
other
Total, other adverse events
103 / 19798 / 194
serious
Total, serious adverse events
68 / 1979 / 194

Outcome results

Primary

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.

ArmMeasureValue (MEDIAN)
Octreotide, BevacizumabCentral Review-based Progression-Free Survival16.6 months
Octreotide, Interferon Alpha-2bCentral Review-based Progression-Free Survival15.4 months
Comparison: According to the intent-to-treat principle, all eligible patients were included in the analysis according to the randomized treatment assignment, regardless of actual treatments received.p-value: 0.5595% CI: [0.73, 1.18]Regression, Cox
Secondary

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.

ArmMeasureValue (MEDIAN)
Octreotide, BevacizumabLocal Progression-Free Survival (Investigator Assessed)15.4 months
Octreotide, Interferon Alpha-2bLocal Progression-Free Survival (Investigator Assessed)10.6 months
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugFistula, GI - Colon/cecum/appendix1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAST, SGOT1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAlbumin, serum-low (hypoalbuminemia)0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAlkaline phosphatase2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAllergic reaction/hypersensitivity1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAnorexia1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAtaxia (incoordination)2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAuditory/Ear-Other (Specify)0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugBilirubin (hyperbilirubinemia)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCNS cerebrovascular ischemia1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCardiac troponin I (cTnI)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCardiac-ischemia/infarction1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCardiopulmonary arrest, cause unknown (non-fatal)0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCholecystitis2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCognitive disturbance1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugColitis1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugConstipation1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCreatinine1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDehydration3 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDental: periodontal disease1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDiarrhea7 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDizziness2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugEdema: limb4 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)13 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugFever in absence of neutropenia, ANC lt1.0x10e9/L0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugALT, SGPT (serum glutamic pyruvic transaminase)0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugFistula, GU - Vagina1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugGlucose, serum-high (hyperglycemia)2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHearing: pts w/o audiogram not enroll monitor prgm0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHeartburn/dyspepsia1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemoglobin0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage, CNS2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Rectum1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Upper GI NOS1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage, pulmonary/upper respiratory - Nose1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage/Bleeding-Other (Specify)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHot flashes/flushes0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHydrocephalus1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHypertension62 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHypotension2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHypoxia1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugINR (of prothrombin time)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugIleus, GI (functional obstruction of bowel)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Blood0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Lung1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Nose0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Ab NOS1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Lung2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - UTI1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Scrotum1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Urinary tract NOS1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInsomnia0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugLeft ventricular systolic dysfunction1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugLeukocytes (total WBC)2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugLipase0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugLymphopenia3 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMental status1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMood alteration - agitation0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMood alteration - anxiety0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMood alteration - depression1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMucositis/stomatitis (clinical exam) - Oral cavity0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMucositis/stomatitis (functional/symp) - Oral cav1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMuscle weakness, not d/t neuropathy - body/general0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugNausea5 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugNeuropathy: motor1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugNeutrophils/granulocytes (ANC/AGC)0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugObstruction, GI - Gallbladder1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugObstruction, GI - Small bowel NOS2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Abdomen NOS7 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Back1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Bone0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Chest wall2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Chest/thorax NOS2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Esophagus1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Extremity-limb1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Gallbladder0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Head/headache9 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Liver0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Muscle1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Stomach0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain-Other (Specify)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPhosphate, serum-low (hypophosphatemia)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPlatelets3 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugProteinuria17 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPruritus/itching0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugRash/desquamation1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugRenal failure0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugRenal/Genitourinary-Other (Specify)2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugSeizure0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugSomnolence/depressed level of consciousness3 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugSyncope (fainting)2 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugThrombosis/embolism (vascular access-related)3 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugThrombosis/thrombus/embolism3 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugTriglyceride, serum-high (hypertriglyceridemia)0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugUlcer, GI - Duodenum1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugUlcer, GI - Stomach1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugUric acid, serum-high (hyperuricemia)1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugVasculitis0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugVessel injury-artery - Aorta1 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugVision-blurred vision0 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugVomiting4 Participants
Octreotide, BevacizumabNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugWeight loss2 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Muscle1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugALT, SGPT (serum glutamic pyruvic transaminase)4 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugLeft ventricular systolic dysfunction0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAST, SGOT6 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugUlcer, GI - Stomach0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAlbumin, serum-low (hypoalbuminemia)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugLeukocytes (total WBC)14 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAlkaline phosphatase6 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Stomach1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAllergic reaction/hypersensitivity0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugLipase1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAnorexia8 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugSomnolence/depressed level of consciousness1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAtaxia (incoordination)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugLymphopenia5 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugAuditory/Ear-Other (Specify)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain-Other (Specify)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugBilirubin (hyperbilirubinemia)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMental status1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCNS cerebrovascular ischemia0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugVomiting2 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCardiac troponin I (cTnI)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMood alteration - agitation2 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCardiac-ischemia/infarction0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPhosphate, serum-low (hypophosphatemia)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCardiopulmonary arrest, cause unknown (non-fatal)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMood alteration - anxiety1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCholecystitis0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugSyncope (fainting)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCognitive disturbance1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMood alteration - depression7 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugColitis0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPlatelets0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugConstipation1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMucositis/stomatitis (clinical exam) - Oral cavity1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugCreatinine0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugUric acid, serum-high (hyperuricemia)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDehydration5 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMucositis/stomatitis (functional/symp) - Oral cav0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDental: periodontal disease0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPneumonitis/pulmonary infiltrates1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDiarrhea9 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugMuscle weakness, not d/t neuropathy - body/general3 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDizziness3 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugThrombosis/embolism (vascular access-related)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugDyspnea (shortness of breath)2 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugNausea9 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugEdema: limb1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPotassium, serum-low (hypokalemia)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugFatigue (asthenia, lethargy, malaise)50 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugNeuropathy: motor1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugFever in absence of neutropenia, ANC lt1.0x10e9/L1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugVision-blurred vision1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugFistula, GI - Colon/cecum/appendix0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugNeutrophils/granulocytes (ANC/AGC)23 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugFistula, GU - Vagina0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugProteinuria1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugGlucose, serum-high (hyperglycemia)5 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugObstruction, GI - Gallbladder0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHearing: pts w/o audiogram not enroll monitor prgm1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugThrombosis/thrombus/embolism1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHeartburn/dyspepsia0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugObstruction, GI - Small bowel NOS1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemoglobin4 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPruritus/itching1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage, CNS0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Abdomen NOS5 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Rectum0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugVasculitis1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage, GI - Upper GI NOS0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Back2 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage, pulmonary/upper respiratory - Nose0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugRash/desquamation1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHemorrhage/Bleeding-Other (Specify)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Bone1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHot flashes/flushes1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugTriglyceride, serum-high (hypertriglyceridemia)1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHydrocephalus0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Chest wall1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHypertension4 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugRenal failure1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHypotension0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Chest/thorax NOS2 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugHypoxia0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugWeight loss3 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugINR (of prothrombin time)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Esophagus0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugIleus, GI (functional obstruction of bowel)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugRenal/Genitourinary-Other (Specify)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Blood1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Extremity-limb1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Lung0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugUlcer, GI - Duodenum0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf (clin/microbio) w/Gr 3-4 neuts - Nose1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Gallbladder1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Ab NOS0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugSeizure2 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - Lung1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Head/headache3 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInf w/normal ANC or Gr 1-2 neutrophils - UTI2 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugVessel injury-artery - Aorta0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Scrotum0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugPain - Liver1 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInfection with unknown ANC - Urinary tract NOS0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugSodium, serum-low (hyponatremia)0 Participants
Octreotide, Interferon Alpha-2bNumber of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study DrugInsomnia1 Participants
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Octreotide, BevacizumabObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Complete Response2 participants
Octreotide, BevacizumabObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Partial Response20 participants
Octreotide, BevacizumabObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Unconfirmed Complete Response0 participants
Octreotide, BevacizumabObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Unconfirmed Partial Response7 participants
Octreotide, BevacizumabObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Stable/No Resposne135 participants
Octreotide, BevacizumabObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Increasing Disease20 participants
Octreotide, BevacizumabObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Symptomatic Deterioration0 participants
Octreotide, BevacizumabObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Assessment Inadequate16 participants
Octreotide, Interferon Alpha-2bObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Assessment Inadequate17 participants
Octreotide, Interferon Alpha-2bObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Complete Response0 participants
Octreotide, Interferon Alpha-2bObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Stable/No Resposne137 participants
Octreotide, Interferon Alpha-2bObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Partial Response8 participants
Octreotide, Interferon Alpha-2bObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Symptomatic Deterioration3 participants
Octreotide, Interferon Alpha-2bObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Unconfirmed Complete Response1 participants
Octreotide, Interferon Alpha-2bObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Increasing Disease30 participants
Octreotide, Interferon Alpha-2bObjective Response (Confirmed and Unconfirmed Complete Response and Partial Response)Unconfirmed Partial Response6 participants
Secondary

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.

ArmMeasureValue (MEDIAN)
Octreotide, BevacizumabOverall Survival35.2 months
Octreotide, Interferon Alpha-2bOverall Survival47.3 months
Secondary

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.

ArmMeasureValue (MEDIAN)
Octreotide, BevacizumabTime to Treatment Failure9.9 months
Octreotide, Interferon Alpha-2bTime to Treatment Failure5.6 months

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026