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Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary - NCT00748657-44109(Clinical Trial 240787)



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City:  Cleveland
State:  
OH
Zip Code: 44109
Conditions: Ovarian Cancer
Purpose: RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent sex cord-stromal tumors of the ovary.
Study summary: OBJECTIVES: Primary - To estimate the anti-tumor activity of bevacizumab by assessing the frequency of objective response in patients with recurrent sex cord-stromal tumors of the ovary. Secondary - To determine the nature and degree of toxicity of this drug in these patients. - To determine the overall survival of these patients. - To determine the progression-free survival of these patients. Tertiary - To quantify expression of angiogenic or lymphangiogenic markers in recurrent stromal tumors of the ovary to determine frequency of alterations and potential utility of biologic agents directed at these proteins for inclusion in future studies. OUTLINE: This is a multicenter study. Patients receive bevacizumab 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 therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.
Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ovarian stromal tumor, including any of the following: - 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 - Recurrent disease - Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan - No tumor involving major vessels - No history or evidence of primary brain tumor or brain metastases by physical exam PATIENT CHARACTERISTICS: Inclusion criteria: - GOG performance status 0-2 - ANC ≥ 1,000/µL - Platelet count ≥ 75,000/µL - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - SGOT < 2.5 times ULN - Alkaline phosphatase < 2.5 times ULN - INR ≤ 1.5 (in-range INR [2-3] if patient is on a stable dose of therapeutic warfarin) - PTT < 1.2 times ULN - Creatinine ≤ 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment Exclusion criteria: - Serious non-healing wound, ulcer, or bone fracture - Active bleeding or pathologic conditions that carry a high risk of bleeding, including any of the following: - Known bleeding disorder - Coagulopathy - History or evidence of other CNS disease by physical exam, including any of the following: - Seizures not controlled with standard medical therapy - Cerebrovascular accident, transient ischemic attack, or subarachnoid hemorrhage within the past 6 months - Sensory and motor neuropathy > grade 1 (according to NCI CTCAE v3.0) - Clinically significant cardiovascular disease, including any of the following: - Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg - Myocardial infarction or unstable angina within the past 6 months - New York Heart Association class II-IV congestive heart failure - Serious cardiac arrhythmic requiring medication - Peripheral vascular disease ≥ grade 2 - Clinically significant peripheral artery disease (e.g., claudication within the past 6 months) - Clinically significant proteinuria (urine protein:creatinine ratio ≥ 1.0) - Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies - Bowel obstruction or requirement for parenteral hydration and/or nutrition - Significant traumatic injury within the past 28 days - Active infection requiring parenteral antibiotics - Other invasive malignancies within the past 5 years, except non-melanoma skin cancer PRIOR CONCURRENT THERAPY: - No prior treatment with bevacizumab or other VEGF inhibitors - No prior cancer treatment that contraindicates study therapy - No major surgical procedure or open biopsy within the past 28 days - No vascular access device placement or core biopsy within the past 7 days - No concurrent major surgery - No other concurrent chemotherapy, radiotherapy, immunotherapy, or hormonal therapy directed against the tumor
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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