Trial Information

A Study of Radiation Therapy and Paclitaxel Carboplatin in Patients with Uterine Papillary Serous Carcinoma

This study is designed to determine if a "sandwich" combination of chemotherapy and radiation can prevent the return of uterine tumor and to evaluate the toxicity and tolerability of this treatment. Patients with uterine cancers are treated with surgery initially. Depending on the type of tumor, some patients are treated with radiation and/or chemotherapy to attempt to cause microscopic tumors to disappear and to prevent the cancer from returning. In this study, radiation is "sandwiched" between paclitaxel/carboplatin chemotherapy to attempt to decrease the chance of the cancer returning in the pelvis or elsewhere in the body. This study will evaluate the tolerability of combining radiation with chemotherapy in this way. It will also evaluate any side effects that patients may experience with this treatment.

Inclusion Criteria:

Histologically documented uterine papillary serous carcinoma (UPSC) with no visible residual disease after surgical staging
Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings
Age > 18 years
ECOG performance status of <2
Written voluntary informed consent

Exclusion 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 tranfused 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 has been treated with myelosuppressive chemotherapy within three weeks prior to study entry.
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.

Mark Einstein, MD, Principal Investigator/ Lorraine Centrilla, RN, Research Nurse
Einstein-Montefiore Institute for Clinical & Translational Research
Montefiore Medical Center
1695 Eastchester Road, Suite 601
Bronx, NY 10461
Phone: 718-405-8082
Email: meinstei@montefiore.org

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

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