Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy
- 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
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
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
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.
Primary Purpose: Treatment
D. Scott McMeekin, MD
Oklahoma University Cancer Institute
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University||Cleveland, Ohio 44106|
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Oklahoma University Medical Center||Oklahoma City, Oklahoma 73104|
|Cancer Care Associates - Midtown Tulsa||Tulsa, Oklahoma 74104|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|