Overview

This trial is active, not recruiting.

Condition ovarian stromal cancer
Treatment bevacizumab
Phase phase 2
Target VEGF
Sponsor National Cancer Institute (NCI)
Start date September 2008
End date January 2013
Trial size 35 participants
Trial identifier NCT00748657, CDR0000613531, GOG-0251, NCI-2009-00611, U10CA027469

Summary

This phase II trial is studying how well bevacizumab works in treating patients with recurrent sex cord-stromal tumors of the ovary. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
bevacizumab anti-VEGF humanized monoclonal antibody
Given IV

Primary Outcomes

Measure
Tumor response rate (complete and partial response) assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Up to 5 years

Secondary Outcomes

Measure
Overall survival
time frame: From entry into the study to death or the date of last contact, up to 5 years
Progression-free survival
time frame: From study entry until disease progression, death or date of last contact, up to 5 years
Frequency and severity of adverse events as assessed by Common Terminology for Adverse Events version 3.0
time frame: Up to 5 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - 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 - 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 - 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 - 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

Additional Information

Official title A Phase II Trial of NCI-Supplied Agent: Bevacizumab (rhuMAB VEGF) (NSC 704865, IND 7921) for Recurrent Sex Cord-Stromal Tumors of the Ovary
Principal investigator Jubilee Brown
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 of this drug 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: This is a multicenter study. 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 therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then periodically thereafter.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).