NCT00005840

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. 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.

Detailed description

OBJECTIVES: I. Determine the safety and maximum tolerated doses of paclitaxel and cisplatin when administered with radiotherapy in patients with stage III or IV endometrial cancer. II. 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.

Conditions

• Endometrial Clear Cell Adenocarcinoma
• Endometrial Serous Adenocarcinoma
• Stage III Uterine Corpus Cancer
• Stage IV Uterine Corpus Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	Given IV
DRUG	Cisplatin	Given IV
RADIATION	Radiation Therapy	Undergo whole abdominal radiation therapy

Timeline

• Start date: 2000-07-01
• Primary completion: 2009-07-01
• First posted: 2003-01-27
• Last updated: 2014-12-31

Locations

1 site across 1 country: United States