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
Primary Purpose
Uterine Carcinosarcoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
paclitaxel
carboplatin
BSI-201 (Iniparib)
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Carcinosarcoma focused on measuring Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression.
Eligibility 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.
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pacitaxel/Carboplatin/Iniparib
Arm Description
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.
Outcomes
Primary Outcome Measures
Clinical response rate
Secondary Outcome Measures
Full Information
NCT ID
NCT00687687
First Posted
May 28, 2008
Last Updated
August 1, 2012
Sponsor
Sanofi
Collaborators
Gynecologic Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00687687
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Gynecologic Oncology Group
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Carcinosarcoma
Keywords
Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pacitaxel/Carboplatin/Iniparib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
Intervention Type
Drug
Intervention Name(s)
BSI-201 (Iniparib)
Other Intervention Name(s)
SAR204550
Intervention Description
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).
Primary Outcome Measure Information:
Title
Clinical response rate
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
New Britain
State/Province
Connecticut
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Research Site
City
Gainsville
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Hinsdale
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Urbana
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Research Site
City
Scarborough
State/Province
Maine
Country
United States
Facility Name
Research Site
City
Kalamazoo
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Research Site
City
Buffalo
State/Province
New York
Country
United States
Facility Name
Research Site
City
New York City
State/Province
New York
Country
United States
Facility Name
Research Site
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Mentor
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Abington
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Wynnewood
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Wyomissing
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Research Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Research Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22634397
Citation
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.
Results Reference
derived
Learn more about this trial
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
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