Papillary Serous Carcinoma of the Endometrium

Completed · Phase 2

Conditions studied: Endometrial Cancer

In brief

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.

Key facts

Study ID

NCT00515073

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2001-04-01

Expected to finish

2013-05-01

Last updated by the study team

2014-07-03

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient must undergo surgical staging within 8 weeks of study entry.
• Patients with mixed histology tumor that include a papillary serous component are eligible.
• Only patients with non-measurable disease can be entered.
• Patients may not have had previous chemotherapy or radiation therapy.
• Patients must have an estimated life expectancy of 12 weeks or greater.
• Patients must have a Zubrod performance status of less than or equal to 2.
• 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.
• Patients must sign an institutionally approved consent form

You may not qualify if…

• Previously treated papillary serous carcinoma with either chemotherapy or radiation therapy.
• Newly diagnosed papillary serous carcinoma of the endometrium, Stage IIIB-IV (patients with disease outside the pelvis).
• 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.
• Patients with a Zubrod status of 3 or greater.
• Patients with an active infection.
• Patients with serious intercurrent medical illness.
• Patients with a recent (within 6 months) history of congestive heart failure, unstable angina or myocardial infarction.

Where it is running

• M. D. Anderson Cancer Center - Orlando — Orlando, Florida, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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