Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy|
|Study Start Date:||July 2000|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
- Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer.
- Assess the time to disease progression and overall survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005840
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital|
|St Louis, Missouri, United States, 63110|
|United States, Ohio|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Lake/University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Oklahoma|
|Oklahoma University Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Midtown Tulsa|
|Tulsa, Oklahoma, United States, 74104|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98104|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||D. Scott McMeekin, MD||Oklahoma University Cancer Institute|