Trial Information

A Pilot Trial of Radiation Therapy "sandwiched" between Paclitaxel and Carboplatin in Patients with Uterine Carcinosarcoma.

The purpose of this study is to determine whether radiation therapy "sandwiched" between paclitaxel/carboplatin chemotherapy is effective in the treatment of uterine carcinosarcoma,and particularly whether this treatment will lessen the chance of the cancer returning in the pelvis or elsewhere in the body.

Patient Inclusion Criteria:

Histologically documented uterine carcinosarcoma with no visible residual disease.
Surgical staging to include total abdominal hysterectomy, bilateral salpingo- oophorectomy, peritoneal washings, and lymph node samplings.
Patients must be entered no more than 12 weeks post operatively.
Age > 18 years.
ECOG performance status of < 2.
Written voluntary informed consent

Patient Exclustion Criteria:

Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:

Serum SGOT and /or SGPT > 2.5 times the institutional upper limit of normal
Total serum bilirubin > 1.5 mg/dl
History of chronic or active hepatitis
Serum creatinine > 2.0 mg/dl
Platelets < 100,000/mm3
Absolute neutrophil count (ANC) < 1500/mm3
Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)

Patient has severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
Patient with any prior chemotherapy or radiotherapy for pelvic malignancy.
Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry.

Loraine Centrilla, RN, Research Coordinator
Einstein-Montefiore Institute for Clinical & Translational Research
Montefiore Medical Center
1695 Eastchester Road Suite 601
Bronx, NY 10461
Phone: 718-405-8082
Email: lcentril@montefiore.org

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Research Center Information: Einstein-Montefiore Institute for Clinical & Translational Research

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