Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Female
Uterine Carcinosarcoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical response rate

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TCD11615

NCT ID:

NCT00687687

Start Date:

May 2008

Completion Date:

December 2011

Related Keywords:

  • Uterine Carcinosarcoma
  • Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression.
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Uterine Neoplasms

Name

Location

Research SiteBoulder, Colorado  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteBaton Rouge, Louisiana  
Research SiteBangor, Maine  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAkron, Ohio  
Research SiteEnid, Oklahoma  
Research SiteAllentown, Pennsylvania  
Research SitePawtucket, Rhode Island  
Research SiteBennington, Vermont  
Research SiteAbington, Virginia  
Research SiteAppleton, Wisconsin