Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial studies how well veliparib works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
BRCA1 Mutation Carrier
BRCA2 Mutation Carrier
Recurrent Fallopian Tube Cancer
Recurrent Ovarian Epithelial Cancer
Recurrent Primary Peritoneal Cavity Cancer
Genetic: DNA analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE II EVALUATION OF THE POLY (ADP-RIBOSE) POLYMERASE (PARP) -1 AND -2 INHIBITOR VELIPARIB (ABT-888) (IND #77840) (NSC #737664) IN THE TREATMENT OF PERSISTENT OR RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER PATIENTS WHO CARRY A GERMLINE BRCA1 OR BRCA2 MUTATION|
- The frequency of patients who have objective tumor response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Frequency and severity of adverse effects as assessed by CTCAE v 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Duration of PFS [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- Duration of OS [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- The proportion of patients who survive progression-free for at least 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
|Study Start Date:||April 2012|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (veliparib)
Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other Name: ABT-888Genetic: DNA analysis
Correlative studiesGenetic: polymorphism analysis
Correlative studiesOther: laboratory biomarker analysis
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).
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.
I. To explore the association between single nucleotide polymorphisms (SNPs) in DNA repair genes (e.g., BRCA1, Fanconi) and clinical characteristics, response, and patient outcome (PFS and OS).
OUTLINE: This is a multicenter study.
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.
Patients may undergo blood and tumor tissue sample collection for single nucleotide polymorphisms in DNA analysis.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.