This phase II trial studies how well veliparib works in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To estimate the proportion of patients who have objective tumor response (complete or partial). II. To determine the frequency and severity of adverse events associated with treatment with veliparib (ABT-888) as assessed by the Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival (PFS) and overall survival (OS). II. To determine the proportion of patients who survive progression-free for at least 6 months. TERTIARY OBJECTIVES: I. To explore the association between single nucleotide polymorphisms (SNPs) in deoxyribonucleic acid (DNA) repair genes (e.g., breast cancer \[BRCA\]1, Fanconi) and clinical characteristics, response, and patient outcome (PFS and OS). OUTLINE: Patients receive veliparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Correlative studies
Given PO
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Gynecologic Oncology Associates-Newport Beach
Newport Beach, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Proportion of Patients With Complete and Partial Tumor Response
Patients with complete and partial tumor response by RECIST V1.1 (per response evaluation criteria in Solid Tumors Criteria (RECIST V1.1) for target lesions and assessed by MRI (CT scan): Complete Response (CR), disappearance of all target lesions (confirmed at \>= 4 weeks); Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions (confirmed at \>= 4 weeks); Overall Response = CR + PR.
Time frame: CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Repeat at other times if clinically indicated.Responses require confirmation at >= 4 wks from first documentation.
Proportion of Patients With Adverse Events as Assessed by CTCAE v4.0
Patients with grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Time frame: After every cycle while on study therapy. Followed for late adverse events up to 30 days after completing therapy.
Duration of PFS
The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (and \>= 5 mm increase of target lesions), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Patients who begin subsequent therapy without progression will be monitored for PFS for 5 years.
Duration of OS
Overall survival
Time frame: Every cycle while patient is receiving protocol therapy. Patients will be monitored for survival after going off therapy for a 5 year period, every 3 months for the first 2 years, then every 6 months for the last 3 years.
The Proportion of Patients Who Survive Progression-free for at Least 6 Months
This outcome captures whether or not the patient survived progression-free for at least 6 months, and is displayed as a proportion.
Time frame: 6 months
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Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
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