Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary

Completed · Phase 2

Conditions studied: Malignant Ovarian Epithelial Tumor, Ovarian Granulosa Cell Tumor, Ovarian Gynandroblastoma, Ovarian Sertoli-Leydig Cell Tumor, Ovarian Sex Cord Tumor With Annular Tubules, Ovarian Sex Cord-Stromal Tumor, Ovarian Sex Cord-Stromal Tumor of Mixed or Unclassified Cell Types, Ovarian Steroid Cell Tumor

In brief

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.

Key facts

Study ID

NCT00748657

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2008-09-22

Expected to finish

2013-01-31

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Northeast Georgia Medical Center-Gainesville — Gainesville, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Hinsdale Hematology Oncology Associates Incorporated — Hinsdale, Illinois, United States
• Sudarshan K Sharma MD Limted-Gynecologic Oncology — Hinsdale, Illinois, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• University of Massachusetts Memorial Health Care — Worcester, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Cancer Center/Fairview Hospital — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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