This phase I trial studies the side effects and the best dose of veliparib when given together with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has come back after a period of improvement, or breast cancer that has spread to other parts of the body. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as liposomal doxorubicin hydrochloride, 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. Giving veliparib together with liposomal doxorubicin hydrochloride may kill more tumor cells.
PRIMARY OBJECTIVES: I. To determine the recommended Phase II dose of ABT-888 (veliparib) given in combination with pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) (PLD - 40 mg/m2 every 4 weeks) in patients with ovarian or breast cancer. SECONDARY OBJECTIVES: I. To determine the toxicity profile of the ABT-888 plus PLD combination. II. To determine the effects of ABT-888 on the pharmacokinetics of PLD. III. To determine the efficacy of ABT-888 plus PLD in ovarian and breast cancer. OUTLINE: This is a dose-escalation study of veliparib. Patients receive veliparib orally (PO) twice daily (BID) on days 1-14 and pegylated liposomal doxorubicin hydrochloride intravenously (IV) over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University/Herbert Irving Cancer Center
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Recommended Phase II dose of veliparib, based on incidence of dose limiting toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 28 days
Frequency of subjects experiencing toxicities in each stratum, assessed and graded according to terminology in the Cancer Therapy Evaluation Program (CTEP) version 4.0 of the CTCAE
Will be tabulated. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.
Time frame: Up to 3 years
Overall survival
Will be assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Time frame: Time from first treatment day until death or until last follow-up, assessed up to 3 years
Progression-free survival
Will be assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.
Time frame: Time from first treatment day until objective or symptomatic progression, assessed up to 3 years
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