A Phase II Trial of Induction Carboplatin and Docetaxel Followed by Radiotherapy Then Consolidation Chemotherapy With Carboplatin and Docetaxel in Stage III, IV and Recurrent Endometrial Cancer
- Determine the time to progression in patients with stage III or IV or recurrent
endometrial cancer treated with induction chemotherapy comprising carboplatin and
docetaxel followed by radiotherapy and consolidation chemotherapy comprising
carboplatin and docetaxel.
- Determine the toxic effects of this regimen in these patients.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30
minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery
from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning
3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin.
After completion of study treatment, patients are followed periodically for 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent of Patients Estimated to be Progression-Free and Alive
This estimate was determined by using a statistical method of analysis (Kaplan-Meier).
1 Year, 2 Years, 3 Years
Melissa A. Geller, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Park Nicollet Cancer Center||St. Louis Park, Minnesota 55416|
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|