Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IP
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Paclitaxel — DRUG
  Given IV or IP
• Veliparib — DRUG
  Given PO

Study Details

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.

Key Dates

First listed

Oct 5, 2009

Start date

Oct 28, 2009

Status verified

Oct 2021

Primary completion

Sep 2, 2016

Completion

Apr 10, 2020

Study Design

Enrollment

431 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Regimen I (paclitaxel, carboplatin, bevacizumab, veliparib)
  Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes (beginning in course 2) on day 1. Patients also receive veliparib PO BID on days 1-21. Treatment repeats every 21 days for 6 courses. Patients then receive bevacizumab alone on day 1. Treatment with bevacizumab repeats every 21 days for 16 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Regimen II (paclitaxel, carboplatin, bevacizumab, veliparib)
  Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Patients also receive carboplatin, bevacizumab, and veliparib as in Regimen I. Treatment repeats every 21 days for 6 courses. Patients then receive bevacizumab alone on day 1. Treatment with bevacizumab repeats every 21 days for 16 courses in the absence of disease progression or unacceptable toxicity.
• Experimental: Regimen III (paclitaxel, cisplatin, bevacizumab, veliparib)
  Patients receive paclitaxel IV over 3 hours on day 1 and IP on day 8, and cisplatin IP on day 1 or 2. Patients also receive bevacizumab and veliparib as in Regimen I. Treatment repeats every 21 days for 6 courses. Patients then receive bevacizumab alone on day 1. Treatment repeats every 21 days for 16 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) occurring in the first or second course of treatment (dose-escalation phase) [ Time Frame: Up to day 42 ]

Locations (23)

Find similar trials in Birmingham, AL

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