Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
NCT00989651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 431
Last updated 2021-10-20
Summary
This phase I trial studies the side effects and best dose of veliparib when given together with carboplatin, paclitaxel, and bevacizumab in treating patients with newly diagnosed stage II-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cells to repair themselves from damage and survive. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab, a type of drug called a monoclonal antibody, blocks tumor growth by targeting certain cells and preventing the growth of new blood vessels that tumors need to grow. Giving veliparib together with carboplatin, paclitaxel, and bevacizumab may kill more tumor cells.
Conditions
- Fallopian Tube Carcinoma
- Fallopian Tube Carcinosarcoma
- Fallopian Tube Clear Cell Adenocarcinoma
- Fallopian Tube Endometrioid Adenocarcinoma
- Fallopian Tube Mucinous Adenocarcinoma
- Fallopian Tube Serous Neoplasm
- Fallopian Tube Transitional Cell Carcinoma
- Fallopian Tube Undifferentiated Carcinoma
- Ovarian Brenner Tumor
- Ovarian Carcinoma
- Ovarian Carcinosarcoma
- Ovarian Clear Cell Adenocarcinoma
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Mucinous Adenocarcinoma
- Ovarian Seromucinous Tumor
- Ovarian Serous Adenocarcinoma
- Ovarian Transitional Cell Carcinoma
- Ovarian Undifferentiated Carcinoma
- Primary Peritoneal Carcinoma
- Primary Peritoneal Serous Adenocarcinoma
- Stage IIA Fallopian Tube Cancer AJCC v6 and v7
- Stage IIA Ovarian Cancer AJCC V6 and v7
- Stage IIB Fallopian Tube Cancer AJCC v6 and v7
- Stage IIB Ovarian Cancer AJCC v6 and v7
- Stage IIC Fallopian Tube Cancer AJCC v6 and v7
- Stage IIC Ovarian Cancer AJCC v6 and v7
- Stage IIIA Fallopian Tube Cancer AJCC v7
- Stage IIIA Ovarian Cancer AJCC v6 and v7
- Stage IIIA Primary Peritoneal Cancer AJCC v7
- Stage IIIB Fallopian Tube Cancer AJCC v7
- Stage IIIB Ovarian Cancer AJCC v6 and v7
- Stage IIIB Primary Peritoneal Cancer AJCC v7
- Stage IIIC Fallopian Tube Cancer AJCC v7
- Stage IIIC Ovarian Cancer AJCC v6 and v7
- Stage IIIC Primary Peritoneal Cancer AJCC v7
- Stage IV Fallopian Tube Cancer AJCC v6 and v7
- Stage IV Ovarian Cancer AJCC v6 and v7
- Stage IV Primary Peritoneal Cancer AJCC v7
Interventions
- BIOLOGICAL
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IP
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Given IV or IP
- DRUG
-
Veliparib
Given PO
Sponsors & Collaborators
-
NRG Oncology
collaborator OTHER -
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Katherine M Bell-McGuinn · NRG Oncology
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-28
- Primary Completion
- 2016-09-02
- Completion
- 2020-04-10
Countries
- United States
Study Locations
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