To estimate the antitumor activity of paclitaxel, carboplatin, plus BSI-201 in patients with recurrent or advanced uterine carcinosarcomas. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
BSI-201 will be administered IV over one hour twice weekly beginning on day 1 (doses of BSI-201 must be separated by at least 2 days).
Research Site
Aurora, Colorado, United States
Research Site
Englewood, Colorado, United States
Research Site
New Britain, Connecticut, United States
Research Site
Orlando, Florida, United States
Research Site
Gainsville, Georgia, United States
Research Site
Clinical response rate
Time frame: 6 months
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Savannah, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site
Chicago, Illinois, United States
Research Site
Hinsdale, Illinois, United States
Research Site
Urbana, Illinois, United States
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