Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have 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. Combining chemotherapy with radiation therapy may kill more tumor cells.
OBJECTIVES: I. Determine the feasibility of doxorubicin and cisplatin followed by whole abdominal radiotherapy in patients with stage III or IV endometrial cancer. II. Determine the acute and chronic toxic effects, in particular, severe and life-threatening gastrointestinal, hepatic, and hematologic toxic effects, of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Number of patients completing the prescribed therapy
Time frame: Up to 9 weeks
Frequency and severity of acute adverse effects as assessed by CTEP CTC version 2.0
Time frame: 3 weeks
Frequency and severity of chronic adverse effects as assessed by CTEP CTC version 2.0
Time frame: Up to 5 years after completion of study treatment
Frequency of severe and life threatening bowel, hepatic, and hematologic toxicity as assessed by CTEP CTC version 2.0
Time frame: Up to 9 weeks
Reason for discontinuing study therapy
Time frame: Up to 9 weeks
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