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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0 [ Time Frame: Up to 30 days post-radiotherapy ]
    Calculated using a 90% conditional likelihood-based confidence bound.
  • Chronic toxicity based on the NCI CTC Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring scheme [ Time Frame: Up to 6 months post-radiotherapy ]


Original Primary Outcome:

Current Secondary Outcome:

  • Number of dose level combinations that will have been evaluated prior to MTD establishment [ Time Frame: Up to 60 months ]
  • Site (local/distant) of treatment failure [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: June 2, 2000
Date Started: July 2000
Date Completion:
Last Updated: December 29, 2014
Last Verified: December 2014