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

August 1, 2012 updated by: Sanofi

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
      • Englewood, Colorado, United States
        • Research Site
    • Connecticut
      • New Britain, Connecticut, United States
        • Research Site
    • Florida
      • Orlando, Florida, United States, 32804
        • Research Site
    • Georgia
      • Gainsville, Georgia, United States
        • Research Site
      • Savannah, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States
        • Research Site
      • Hinsdale, Illinois, United States
        • Research Site
      • Urbana, Illinois, United States
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70806
        • Research Site
    • Maine
      • Scarborough, Maine, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Research Site
      • St. Louis, Missouri, United States, 63110
        • Research Site
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Research Site
    • New York
      • 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
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
      • Charlotte, North Carolina, United States
        • Research Site
      • Charlotte, North Carolina, United States, 28204
        • Research Site
      • Winston-salem, North Carolina, United States, 27157
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States, 43235
        • Research Site
      • Mentor, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site
      • Tulsa, Oklahoma, United States
        • Research Site
    • Pennsylvania
      • Abington, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
      • Wynnewood, Pennsylvania, United States
        • Research Site
      • Wyomissing, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Research Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Research Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Research Site
      • Roanoke, Virginia, United States, 24014
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression. Histologic confirmation of the original primary tumor is required.
  • All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be greater than 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or greater than 10 mm when measured by spiral CT.
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST (Section 8.1). Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
  • Patients must have a GOG Performance Status of 0, 1, or 2.
  • Adequate bone marrow,renal, hepatic, and neurological function

Exclusion Criteria:

  • Patients who have received prior cytotoxic chemotherapy for management of uterine carcinosarcoma.
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in Sections 3.23 and 3.24 are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine carcinosarcoma within the last five years are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Patients MAY have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
  • Patients who have symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
  • Patients who have a significant history of cardiac disease, i.e., myocardial infarction (MI) within 6 months of study registration, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or uncontrolled hypertension.
  • Patients who have a history of seizure disorder or are currently on anti-seizure medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pacitaxel/Carboplatin/Iniparib
Participants will be administered pacitaxel, carboplatin and BSI-201 (Iniparib) in 21 day treatment cycles. Treatment will continue until disease progression or adverse effects prohibit further therapy.
Drug: paclitaxel
Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
Drug: carboplatin
Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
Drug: BSI-201 (Iniparib)
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).
Other Names:
  • SAR204550

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical response rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Collaborators

Gynecologic Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 30, 2008

First Posted (Estimate)

June 2, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCD11615
  • GOG 0232C
  • 20070103 (Other Identifier: BiPar)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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