Papillary Serous Carcinoma of the Endometrium
Condition: Endometrial Cancer
MeSH terms: Carcinoma; Endometrial Neoplasms; Cystadenocarcinoma, Serous
Intervention: Paclitaxel; Pelvic Radiation; Dexamethasone; Cimetidine; Diphenhydramine
Intervention description: 50 mg/m^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.; Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.; 20 mg IV given 30 minutes prior to chemotherapy; 300 mg IV given 30 minutes prior to chemotherapy; 50 mg IV given 30 minutes prior to chemotherapy
Intervention MeSH terms: Diphenhydramine; Promethazine; Dexamethasone; Paclitaxel; Cimetidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Healthy volunteers: No
Keywords: Endometrial Cancer; Papillary Serous Carcinoma; Pelvic Radiation Therapy; Paclitaxel; Taxol

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.
    

Eligibility 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.