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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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00687687
Collaborator
Gynecologic Oncology Group (Other)
22
Enrollment
40
Locations
1
Arm
43
Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2008
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical response rate [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aurora Colorado United States
    2 Research Site Englewood Colorado United States
    3 Research Site New Britain Connecticut United States
    4 Research Site Orlando Florida United States 32804
    5 Research Site Gainsville Georgia United States
    6 Research Site Savannah Georgia United States
    7 Research Site Chicago Illinois United States 60612
    8 Research Site Chicago Illinois United States
    9 Research Site Hinsdale Illinois United States
    10 Research Site Urbana Illinois United States
    11 Research Site Indianapolis Indiana United States 46260
    12 Research Site Baton Rouge Louisiana United States 70806
    13 Research Site Scarborough Maine United States
    14 Research Site Kalamazoo Michigan United States
    15 Research Site Springfield Missouri United States 65804
    16 Research Site St. Louis Missouri United States 63110
    17 Research Site Camden New Jersey United States 08103
    18 Research Site Brooklyn New York United States
    19 Research Site Buffalo New York United States
    20 Research Site New York City New York United States
    21 Research Site Stony Brook New York United States
    22 Research Site Chapel Hill North Carolina United States
    23 Research Site Charlotte North Carolina United States 28204
    24 Research Site Charlotte North Carolina United States
    25 Research Site Winston-salem North Carolina United States 27157
    26 Research Site Cleveland Ohio United States
    27 Research Site Columbus Ohio United States 43235
    28 Research Site Columbus Ohio United States
    29 Research Site Mentor Ohio United States
    30 Research Site Oklahoma City Oklahoma United States 73104
    31 Research Site Tulsa Oklahoma United States
    32 Research Site Abington Pennsylvania United States
    33 Research Site Pittsburgh Pennsylvania United States
    34 Research Site Wynnewood Pennsylvania United States
    35 Research Site Wyomissing Pennsylvania United States
    36 Research Site Providence Rhode Island United States 02905
    37 Research Site Burlington Vermont United States 05401
    38 Research Site Richmond Virginia United States 23298
    39 Research Site Roanoke Virginia United States 24014
    40 Research Site Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • Sanofi
    • Gynecologic Oncology Group

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT00687687
    Other Study ID Numbers:
    • TCD11615
    • GOG 0232C
    • 20070103
    • NCT00588744
    First Posted:
    Jun 2, 2008
    Last Update Posted:
    Aug 7, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Sanofi
    Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression.
    Additional relevant MeSH terms:
    Carcinosarcoma
    Mixed Tumor, Mullerian
    Uterine Neoplasms
    Paclitaxel
    Carboplatin
    Iniparib

    Study Results

    No Results Posted as of Aug 7, 2012