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

Uterine Carcinosarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687687
• Other study ID #: TCD11615
• Secondary ID: GOG 0232C2007010
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2008
• Last updated: August 1, 2012
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00588744

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinosarcoma
• Mixed Tumor, Mullerian
• Uterine Carcinosarcoma
• Uterine Neoplasms

Intervention

Drug:
• paclitaxel
Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
• carboplatin
Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
• 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).

Locations

Country	Name	City	State
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Aurora	Colorado
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Brooklyn	New York
United States	Research Site	Buffalo	New York
United States	Research Site	Burlington	Vermont
United States	Research Site	Camden	New Jersey
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	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Englewood	Colorado
United States	Research Site	Gainsville	Georgia
United States	Research Site	Hinsdale	Illinois
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Kalamazoo	Michigan
United States	Research Site	Madison	Wisconsin
United States	Research Site	Mentor	Ohio
United States	Research Site	New Britain	Connecticut
United States	Research Site	New York City	New York
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Providence	Rhode Island
United States	Research Site	Richmond	Virginia
United States	Research Site	Roanoke	Virginia
United States	Research Site	Savannah	Georgia
United States	Research Site	Scarborough	Maine
United States	Research Site	Springfield	Missouri
United States	Research Site	St. Louis	Missouri
United States	Research Site	Stony Brook	New York
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Urbana	Illinois
United States	Research Site	Winston-salem	North Carolina
United States	Research Site	Wynnewood	Pennsylvania
United States	Research Site	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Gynecologic Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response rate		6 months	No