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
NCT ID: NCT00687687
Last Updated: 2012-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2008-05-31
2011-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Gynecologic Oncology Group
NETWORK
Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
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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, 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
Countries
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References
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Aghajanian C, Sill MW, Secord AA, Powell MA, Steinhoff M. Iniparib plus paclitaxel and carboplatin as initial treatment of advanced or recurrent uterine carcinosarcoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2012 Sep;126(3):424-7. doi: 10.1016/j.ygyno.2012.05.024. Epub 2012 May 24.
Other Identifiers
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GOG 0232C
Identifier Type: -
Identifier Source: secondary_id
20070103
Identifier Type: OTHER
Identifier Source: secondary_id
TCD11615
Identifier Type: -
Identifier Source: org_study_id
NCT00588744
Identifier Type: -
Identifier Source: nct_alias