Papillary Serous Carcinoma of the Endometrium

Phase 2

Completed

• Conditions: Endometrial Cancer
• Interventions: Drug: Paclitaxel; Radiation: Pelvic Radiation; Drug: Dexamethasone; Drug: Cimetidine; Drug: Diphenhydramine

• Registration Number: NCT00515073
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed Description

Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may cause them to die.

If you are found to be eligible to take part in this study, you will begin treatment. You will have radiation treatment to your pelvis (hip area) every day (Monday - Friday) for a total of 25 treatments. Each treatment should take about 20 minutes to complete.

After the radiation treatment, you will receive a type of radiation called a "vaginal cuff boost." The vaginal cuff boost involves a small device being inserted into the vagina to treat the back of the vagina with a high dose of radiation. The applicator is similar to placing a large tampon in the vagina. This internal treatment takes about 30 minutes for each treatment. This is separate from the external radiation treatments that are given.

While you are receiving radiation treatment, and then afterwards, you will also receive chemotherapy with paclitaxel. During the radiation period, you will receive paclitaxel by vein over 1 hour, on Days 1, 8, 15, 22, and 29. Starting 4-6 weeks after radiation treatment is finished, you will receive paclitaxel at a larger dose, given over 3 hours each time, once every 21 days (3 weeks). You will receive up to 4 "cycles" of chemotherapy, each cycle lasting 21 days.

You will be given certain drugs about 30 minutes before your chemotherapy treatments to help control possible side effects, like allergic reactions. These drugs include dexamethasone, diphenhydramine (Benadryl), and cimetidine.

You will have several tests performed throughout the study. Before each cycle of chemotherapy and one month after the last cycle of chemotherapy is given, quality of life and symptom assessment forms will be completed. These questionnaires should only take about 15 minutes to complete.

While you are on chemotherapy treatment, you will have tests performed before each chemotherapy treatment. This will involve blood (about 1 tablespoon) drawn for routine tests, and a review of your symptoms by the study staff.

Once you are off study treatment, you will be asked to return to the clinic for follow-up visits. These visits will occur every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year after that. At these visits, you will have a physical and pelvic exam performed, along with blood (about 1 tablespoon) drawn for routine tests. Chest x-rays will usually be done once a year and any other diagnostic exams will only be done if your doctor thinks they are needed.

This is an investigational study. There are no standard treatments for this type of endometrial cancer, but radiation and chemotherapy are common treatments. This combination of chemotherapy and radiation is considered experimental. Up to 49 patients will take part in this multicenter study. Up to 44 participants will be enrolled at M. D. Anderson.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2007-08-09
• Study First Submitted QC: 2007-08-09
• Study First Posted: 2007-08-13
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-05
• Results First Submitted: 2014-05-30
• Results First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Results First Posted: 2014-07-03
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel (Taxol) + Pelvic Radiation	Pelvic Radiation	Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Paclitaxel (Taxol) + Pelvic Radiation	Paclitaxel	Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Paclitaxel (Taxol) + Pelvic Radiation	Cimetidine	Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Paclitaxel (Taxol) + Pelvic Radiation	Dexamethasone	Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
Paclitaxel (Taxol) + Pelvic Radiation	Diphenhydramine	Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.

Primary Outcome Measures

Name	Time	Method
Overall Survival at 2 Years and 5 Years	Assessment at 2 years and 5 years	The percentage of participants who are still alive for A designated period of time (2 years and 5 years) after starting treatment. Continual Assessments every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year.

Trial Locations

Locations (2)

M. D. Anderson Cancer Center - Orlando; 🇺🇸 Orlando, Florida, United States

UT MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States