A Randomized Study of Doxorubicin Plus Cisplatin Versus Doxorubicin Plus Cisplatin Plus 3-Hour Paclitaxel With G-CSF Support in Patients With Primary Stage III & IV or Recurrent Endometrial Carcinoma

Date de début de l'étude : 1 décembre 1998

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