A Phase III Trial of Ifosfamide (NSC #109274) Versus Ifosfamide Plus Paclitaxel (NSC #125973) in Patients With Advanced, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus

Fecha de inicio: 1 de noviembre de 1997

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV, refractory, or recurrent heterologous or homologous carcinosarcoma (mixed mesodermal tumors) of the uterus Must not be amenable to curative-intent therapy Must have measurable disease consisting of abdominal, pelvic, chest or other masses that can be defined in at least 2 dimensions by palpation, x-ray, MRI, computed tomography or ultrasound If measured by MRI, computed tomography or ultrasound, the lesion must have a minimal tumor measurement of 1 cm PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Albumin at least 3 g/dL Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No history of congestive heart failure No unstable angina No myocardial infarction within the past 6 months Other: No septicemia No severe infection No acute hepatitis No gastrointestinal bleeding At least 5 years since any other invasive malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for carcinosarcoma of the uterus Endocrine therapy: Not specified Radiotherapy: At least 6 weeks since radiotherapy for current malignancy At least 3 months since radiotherapy if delivered to site of measurable disease Surgery: Not specified