Papillary Serous Carcinoma of the Endometrium

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Primary Objectives:

• To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary serous carcinoma of the endometrium for both local control and overall survival.

• To evaluate the toxicity of Paclitaxel and pelvic radiation.

• To collect and evaluate patients' quality of life/symptom assessment data.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Cimetidine; Dexamethasone; Diphenhydramine; Paclitaxel; Promethazine

Criteria

Inclusion Criteria:

1. Patient must undergo surgical staging within 8 weeks of study entry.

2. Patients with mixed histology tumor that include a papillary serous component are eligible.

3. Only patients with non-measurable disease can be entered.

4. Patients may not have had previous chemotherapy or radiation therapy.

5. Patients must have an estimated life expectancy of 12 weeks or greater.

6. Patients must have a Zubrod performance status of less than or equal to 2.

7. Patients must have adequate bone marrow, renal and hepatic function: with white blood count (WBC) greater than or equal to 3000; Absolute neutrophil count (ANC) greater than or equal to 1500; Platelets greater than or equal to 100,000; glutamic-pyruvic transaminase (SGPT) less than or equal to 2 times the upper limit of normal; Total bilirubin less than or equal to 2.5mg/dl.

8. Patients must sign an institutionally approved consent form

Exclusion Criteria:

1. Previously treated papillary serous carcinoma with either chemotherapy or radiation therapy.

2. Newly diagnosed papillary serous carcinoma of the endometrium, Stage IIIB-IV (patients with disease outside the pelvis).

3. Patients who have a history of other malignancy, with the exception of non-melanomatous skin cancer, unless in complete remission and off all therapy for that disease for a minimum of 5 years.

4. Patients with a Zubrod status of 3 or greater.

5. Patients with an active infection.

6. Patients with serious intercurrent medical illness.

7. Patients with a recent (within 6 months) history of congestive heart failure, unstable angina or myocardial infarction.