Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary (NCT00748657) | Clinical Trial Compass
CompletedPhase 2
Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary
United States36 participantsStarted 2008-09-22
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Neuropa…
What they're measuring
1
Tumor Response
Timeframe: 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