Recurrent Ovarian Carcinoma Clinical Trial
Official title:
A Phase I Trial of Pegylated Liposomal Doxorubicin (PLD), Carboplatin and NCI Supplied Veliparib (ABT-888), and NCI Supplied Bevacizumab in Recurrent Platinum Sensitive Ovarian, Primary Peritoneal and Fallopian Tube Cancer
This phase I trial studies the side effects and the best dose of veliparib when given together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab in treating patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has returned after previous treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and carboplatin, may stop the growth of tumor cells by, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth by blocking the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumors by blocking the growth of new blood vessels necessary for tumor growth. Giving veliparib together with pegylated liposomal doxorubicin hydrochloride, carboplatin, and bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated doses (MTD) and dose-limiting toxicities of two
different regimens of ABT-888 (veliparib) when administered with carboplatin and PLD (Doxil,
Lipodox) (pegylated liposomal doxorubicin hydrochloride) in recurrent, platinum-sensitive
epithelial ovarian, fallopian tube, or primary peritoneal cancer.
II. To assess the toxicity of these regimens using the Cancer Therapy Evaluation Program
(CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
version 4.0.
III. To examine the tolerability of these treatment regimens in combination with bevacizumab
at the MTD.
SECONDARY OBJECTIVES:
I. To estimate the objective response rate (complete and partial) in patients with measurable
disease.
TERTIARY OBJECTIVES:
I. To examine the relationships between platinum-free interval, activity of ABT-888
(objective response rate) and measures of breast cancer susceptibility gene 1/2 (BRCA1/2)
status including mutations, alterations, rearrangements, promoter methylation, and
immunohistochemical expression).
OUTLINE: This is a dose-escalation study of veliparib. Patients are assigned to 1 of 2
treatment arms.
REGIMEN I: Patients receive veliparib orally (PO) twice daily (BID) on days 1-7, and
pegylated liposomal doxorubicin hydrochloride intravenously (IV) over 1 hour and carboplatin
IV over 30 minutes on day 1.
REGIMEN II: Patients receive veliparib PO BID on days 1-28, and pegylated liposomal
doxorubicin hydrochloride and carboplatin as in Regimen I.
BEVACIZUMAB: Once the MTD for veliparib has been determined, patients also receive
bevacizumab IV over 30-90 minutes on days 1 and 15.
In both arms, treatment repeats every 28 days for up to 10 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up quarterly for 1 year.
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