Study:
A PHASE I STUDY OF INTRAVENOUS CARBOPLATIN/PACLITAXEL OR INTRAVENOUS AND INTRAPERITONEAL PACLITAXEL/CISPLATIN IN COMBINATION WITH CONTINUOUS OR INTERMITTENT/ CTEP-SUPPLIED AGENT ABT-888 (NSC #737664) AND CTEP-SUPPLIED AGENT BEVACIZUMAB (NSC #704865) IN NEWLY DIAGNOSED PATIENTS WITH PREVIOUSLY UNTREATED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER
Rationale:
Drugs used in chemotherapy, such as carboplatin, cisplatin, and paclitaxel, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. 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 stop the growth of tumor cells by blocking blood flow to the tumor. veliparib may stop
the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
carboplatin or cisplatin, paclitaxel, and bevacizumab together with veliparib may kill more
tumor cells.
Purpose:
This phase I trial is studying the side effects and best dose of ABT-888 when given together
with carboplatin, paclitaxel, and bevacizumab in treating patients with newly diagnosed
stage II, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or
primary peritoneal cancer. 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 or by
stopping them from dividing. 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 stop the growth of tumor cells by blocking blood flow to the tumor. ABT-888 may stop the
growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving
carboplatin, paclitaxel, and bevacizumab together with ABT-888 may kill more tumor cells
Study Status: Recruiting
Recruiting:
Steven E. Waggoner 800-641-2422
| Condition |
Intervention |
Phase |
Brenner Tumor
Ovarian Carcinosarcoma
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mixed Epithelial Carcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Stage IIA Fallopian Tube Cancer
Stage IIA Ovarian Epithelial Cancer
Stage IIA Primary Peritoneal Cavity Cancer
Stage IIB Fallopian Tube Cancer
Stage IIB Ovarian Epithelial Cancer
Stage IIB Primary Peritoneal Cavity Cancer
Stage IIC Fallopian Tube Cancer
Stage IIC Ovarian Epithelial Cancer
Stage IIC Primary Peritoneal Cavity Cancer
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Epithelial Cancer
Stage IIIA Primary Peritoneal Cavity Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Epithelial Cancer
Stage IIIB Primary Peritoneal Cavity Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Epithelial Cancer
Stage IIIC Primary Peritoneal Cavity Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Epithelial Cancer
Stage IV Primary Peritoneal Cavity Cancer |
Drug: paclitaxel
Drug: carboplatin
Biological: bevacizumab
Drug: veliparib
Other: laboratory biomarker analysis |
Phase 1 |
Verified by
National Cancer Institute (NCI)
January, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00989651
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Katherine Bell-McGuinn., Principal Investigator