Endometrial Cancer
Conditions
Keywords
stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of doxorubicin and cisplatin with or without paclitaxel and G-CSF in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
Detailed description
OBJECTIVES: * Determine whether the addition of paclitaxel, using filgrastim (G-CSF) support, to standard doxorubicin/cisplatin chemotherapy produces improvement in the frequency of objective response, progression-free survival, or overall survival in patients with stage III, stage IV, or recurrent endometrial carcinoma. * Compare the toxicities of these two regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive doxorubicin IV over 15-30 minutes, followed immediately by cisplatin IV over 1 hour. * Arm II: Patients receive doxorubicin and cisplatin as in arm I on day 1. On day 2, patients receive paclitaxel IV over 3 hours. Patients also receive filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for at least 10 days. Courses are repeated every 21 days. Treatment continues for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 240 patients (120 per arm) will be accrued for this study within 21 months.
Interventions
BIOLOGICALfilgrastim
DRUGcisplatin
DRUGdoxorubicin hydrochloride
DRUGpaclitaxel
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed primary stage III, stage IV, or recurrent endometrial carcinoma * Very poor potential for cure by radiotherapy or surgery alone or in combination * Measurable disease * Disease in an irradiated field as the only site of measurable disease allowed provided there has been clear progression since completion of radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Platelet count at least 100,000/mm\^3 * Granulocyte count at least 1,500/mm\^3 Hepatic * SGPT no greater than 3 times upper limit of normal * Bilirubin normal Renal * Creatinine no greater than 1.6 mg/dL Cardiovascular * LVEF at least 50% within past 6 months * No uncontrolled angina * No third-degree or complete heart block unless a pacemaker is in place Neurologic * No serious peripheral neuropathy Other * No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer * No uncontrolled infection * No sensitivity to E. coli-derived drug preparations PRIOR CONCURRENT THERAPY: Biologic therapy * Prior biologic therapy allowed * No concurrent biologic therapy Chemotherapy * No prior cytotoxic chemotherapy, including chemotherapy used for radiation sensitization * No prior chemotherapy for any prior malignancy Endocrine therapy * Prior hormone therapy allowed * No concurrent hormone therapy Radiotherapy * At least 4 weeks since prior radiotherapy to the whole pelvis or to over 50% of the spine Surgery * Not specified
Countries
Canada, United States
Outcome results
None listed