Malignant Ovarian Epithelial Tumor, Ovarian Granulosa Cell Tumor, Ovarian Gynandroblastoma, Ovarian Sertoli-Leydig Cell Tumor, Ovarian Sex Cord-Stromal Tumor, Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types, Ovarian Sex Cord Tumor With Annular Tubules, Ovarian Steroid Cell Tumor
Conditions
Brief summary
This phase II trial studies how well bevacizumab works in treating patients with sex cord-stromal tumors of the ovary that have come back. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
Detailed description
PRIMARY OBJECTIVES: I. To estimate the anti-tumor activity of bevacizumab by assessing frequency of objective response in patients with recurrent sex cord-stromal tumors of the ovary who have measurable disease. SECONDARY OBJECTIVES: I. To determine the nature and degree of toxicity in these patients. II. To determine the overall survival and progression-free survival of these patients. TERTIARY OBJECTIVES: I. To quantify expression of angiogenic or lymphangiogenic markers in recurrent stromal tumors of the ovary to determine the frequency of alterations and potential utility of biologic agents directed at these proteins for inclusion in future studies. OUTLINE: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.
Interventions
BIOLOGICALBevacizumab
Given IV
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
NRG Oncology
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with histologically confirmed recurrent ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor \[androblastoma\], steroid \[lipid\] cell tumor, gynandroblastoma, unclassified sex cord-stromal tumor, sex cord tumor with annular tubules) * Patients must have measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria * Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each ?target? lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \>= 10 mm when measured by spiral CT * Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2 * Patients of childbearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control * Patients who have met the pre-entry requirements specified * There are no restrictions on prior therapy; however, patients cannot have previously had treatment with bevacizumab * Absolute neutrophil count (ANC) \>= 1,000/?l * Platelets greater than or equal to 75,000/?l * Creatinine =\< 1.5 x institutional upper limit normal (ULN) * Bilirubin =\< 1.5 x ULN * Serum glutamic oxaloacetic transaminase (SGOT) less 2.5 x ULN * Alkaline phosphatase less 2.5 x ULN * Neuropathy (sensory and motor) less than or equal to Common Terminology Criteria for Adverse Events (CTCAE) version (v)3.0 grade 1 * Prothrombin time (PT) such that international normalized ratio (INR) is =\< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) \< 1.2 times the upper limit of normal * Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion criteria
* Patients with newly diagnosed disease * Patients with serious non-healing wound, ulcer, or bone fracture * Patients who have received prior therapy with bevacizumab or other inhibitors of vascular endothelial growth factor (VEGF) * Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels * Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within 6 months of the first date of treatment on this study * Patients with clinically significant cardiovascular disease; this includes: * Uncontrolled hypertension, defined as systolic \> 150 mm Hg or diastolic \> 90 mm Hg * Myocardial infarction or unstable angina within 6 months prior to registration * New York Heart Association (NYHA) grade II or greater congestive heart failure * Serious cardiac arrhythmic requiring medication. * Grade 2 or greater peripheral vascular disease * Patients with GOG performance grade of 3 or 4 * Patients with clinically significant peripheral arterial disease; e.g., claudication within 6 months * Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies * Patients with clinically significant proteinuria; urine protein should be screened by urine protein-creatinine ratio (UPCR); the UPCR has been found to correlate directly with the amount of protein excreted in a 24 hour urine collection; specifically; a UPCR of 1.0 is equivalent to 1.0 gram of protein in a 24 hour urine collection; obtain at least 4 ml of a random urine sample in a sterile container (does not have to be a 24 hour urine); send sample to lab with request for urine protein and creatinine levels (separate requests); the lab will measure protein concentration (mg/dL) and creatinine concentration (mg/dL); the UPCR is derived as follows: protein concentration (mg/dL)/creatinine (mg/dL); patients must have a UPCR \< 1.0 to allow participation in the study * Patients with a history of cardiovascular accident (CVA) within 6 months prior to registration * Patients with any signs of bowel obstruction or patients who require parenteral hydration and/or nutrition * Patients whose circumstances do not permit completion of the study or the required follow-up * Patients who are pregnant or nursing; patients who may become pregnant must agree to use contraceptive measures during the study and for at least 3 months after the completion of bevacizumab therapy * Patients who have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipate the need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study * Patients with active infection requiring parenteral antibiotics * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response | Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels | Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival | Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels | Progression-Free Survival is the period from study entry until disease progression, death or date of last contact. |
| Overall Survival | From study entry to death or last contact, up to 5 years. | The observed length of life from entry into the study to death or the date of last contact. |
| Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Up to 5 years | Adverse Events at least possibly related to study agent. |
Countries
United States
Participant flow
Recruitment details
The study was activated on 9/22/2008 and closed to accrual on 1/31/2011 (suspended from 1/4/2010 to 8/9/2010).
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Bevacizumab |
|---|---|
| Age, Customized 20-29 | 0 participants |
| Age, Customized 30-39 | 1 participants |
| Age, Customized 40-49 | 8 participants |
| Age, Customized 50-59 | 12 participants |
| Age, Customized 60-69 | 11 participants |
| Age, Customized 70-79 | 4 participants |
| Age, Customized 80-89 | 0 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 36 / 36 |
| serious Total, serious adverse events | 13 / 36 |
Outcome results
Primary
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0
Time frame: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels
Population: Eligible and Treated Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bevacizumab | Tumor Response | 16.7 percentage of patients |
Secondary
Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0
Adverse Events at least possibly related to study agent.
Time frame: Up to 5 years
Population: Eligible and evaluable patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Syndromes | 35 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Endocrine | 33 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Cardiac | 15 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Allergy/Immunology | 23 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Dermatologic | 17 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Vascular | 35 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Lymphatics | 31 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Constitutional | 12 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Coagulation | 35 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Infection | 23 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Hemorrhage | 17 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Neurological | 22 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Metabolic | 13 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Hematologic | 33 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Sexual/Reproductive | 32 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Anemia | 21 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pulmonary | 12 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Ocular/Visual | 30 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Neurosensory | 21 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Thrombocytopenia | 28 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pain | 1 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Leukopenia | 32 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Death, Not CTC coded | 35 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Auditory/Ear | 29 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Musculoskeletal | 30 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Genitourinary/Renal | 29 Participants |
| Bevacizumab | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Gastrointestinal | 6 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Allergy/Immunology | 11 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Musculoskeletal | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Neurosensory | 13 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Neurological | 12 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pain | 11 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Ocular/Visual | 6 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Auditory/Ear | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Cardiac | 6 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Syndromes | 1 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Coagulation | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Vascular | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Constitutional | 10 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Dermatologic | 14 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Endocrine | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Gastrointestinal | 10 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Genitourinary/Renal | 5 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Leukopenia | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Thrombocytopenia | 8 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Sexual/Reproductive | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Anemia | 7 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Hematologic | 2 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Hemorrhage | 18 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Infection | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Death, Not CTC coded | 0 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pulmonary | 20 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Lymphatics | 4 Participants |
| Grade 1 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Metabolic | 10 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Vascular | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Endocrine | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Syndromes | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Gastrointestinal | 15 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Auditory/Ear | 6 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Metabolic | 8 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Genitourinary/Renal | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Death, Not CTC coded | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Sexual/Reproductive | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Ocular/Visual | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Thrombocytopenia | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Hematologic | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Lymphatics | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Anemia | 7 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Neurological | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Neurosensory | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pain | 16 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Hemorrhage | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pulmonary | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Coagulation | 0 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Leukopenia | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Allergy/Immunology | 2 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Musculoskeletal | 1 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Constitutional | 13 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Cardiac | 9 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Infection | 11 Participants |
| Grade 2 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Dermatologic | 4 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Neurological | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Infection | 2 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Endocrine | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pain | 8 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Vascular | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Auditory/Ear | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pulmonary | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Sexual/Reproductive | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Dermatologic | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Musculoskeletal | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Constitutional | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Genitourinary/Renal | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Gastrointestinal | 5 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Hemorrhage | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Neurosensory | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Death, Not CTC coded | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Leukopenia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Metabolic | 3 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Cardiac | 5 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Thrombocytopenia | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Coagulation | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Ocular/Visual | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Allergy/Immunology | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Lymphatics | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Syndromes | 0 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Anemia | 1 Participants |
| Grade 3 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Hematologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Musculoskeletal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Ocular/Visual | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Leukopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Hematologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Allergy/Immunology | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Auditory/Ear | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Cardiac | 1 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Coagulation | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Constitutional | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Dermatologic | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Endocrine | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Gastrointestinal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Genitourinary/Renal | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Thrombocytopenia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Anemia | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Hemorrhage | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Infection | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Lymphatics | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Metabolic | 2 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Neurosensory | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Neurological | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pain | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pulmonary | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Sexual/Reproductive | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Syndromes | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Vascular | 0 Participants |
| Grade 4 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Death, Not CTC coded | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Infection | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Hemorrhage | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Genitourinary/Renal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Hematologic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pulmonary | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Anemia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Thrombocytopenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Leukopenia | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Gastrointestinal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Ocular/Visual | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Sexual/Reproductive | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Endocrine | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Dermatologic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Musculoskeletal | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Syndromes | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Constitutional | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Coagulation | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Cardiac | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Auditory/Ear | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Death, Not CTC coded | 1 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Vascular | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Other Neurological | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Neurosensory | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Metabolic | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Allergy/Immunology | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Pain | 0 Participants |
| Grade 5 (CTCAE v 3.0) | Number of Participants With Episodes and Grade of Adverse Events as Assessed by Common Terminology for Adverse Events Version 3.0 | Lymphatics | 0 Participants |
Secondary
Overall Survival
The observed length of life from entry into the study to death or the date of last contact.
Time frame: From study entry to death or last contact, up to 5 years.
Population: Eligible and treated patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Overall Survival | NA Months |
Secondary
Progression-free Survival
Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time frame: Every other cycle for 6 months; then every 3 months for two years; then every six months for three years; and at any other time if clinically indicated based on symptoms, physical signs suggestive of progressive disease or rising serum tumor maker levels
Population: Eligible and Treated Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bevacizumab | Progression-free Survival | 9.3 Months |