Spots Global Cancer Trial Database for Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
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Trial Identification
Brief Title: Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
Official Title: A Phase II Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma
Study ID: NCT00687687
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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, 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
Research Site, Indianapolis, Indiana, United States
Research Site, Baton Rouge, Louisiana, United States
Research Site, Scarborough, Maine, United States
Research Site, Kalamazoo, Michigan, United States
Research Site, Springfield, Missouri, United States
Research Site, St. Louis, Missouri, United States
Research Site, Camden, New Jersey, United States
Research Site, Brooklyn, New York, United States
Research Site, Buffalo, New York, United States
Research Site, New York City, New York, United States
Research Site, Stony Brook, New York, United States
Research Site, Chapel Hill, North Carolina, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Winston-salem, North Carolina, United States
Research Site, Cleveland, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Mentor, Ohio, United States
Research Site, Oklahoma City, Oklahoma, United States
Research Site, Tulsa, Oklahoma, United States
Research Site, Abington, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Wynnewood, Pennsylvania, United States
Research Site, Wyomissing, Pennsylvania, United States
Research Site, Providence, Rhode Island, United States
Research Site, Burlington, Vermont, United States
Research Site, Richmond, Virginia, United States
Research Site, Roanoke, Virginia, United States
Research Site, Madison, Wisconsin, United States
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
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