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

This study has been completed.
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00687687
First received: May 28, 2008
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Uterine Carcinosarcoma
Drug: paclitaxel
Drug: carboplatin
Drug: BSI-201 (Iniparib)
Phase 2

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Clinical response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: May 2008
Study Completion Date: December 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SAR204550

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687687

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

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00687687     History of Changes
Obsolete Identifiers: NCT00588744
Other Study ID Numbers: TCD11615, GOG 0232C, 20070103
Study First Received: May 28, 2008
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

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
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Sarcoma
Neoplasms, Connective and Soft Tissue
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014