A Randomized Phase III Study of Cisplatin Versus Cisplatin Plus Topotecan Versus MVAC in Stage IVB, Recurrent or Persistent Squamous Cell Carcinoma of the Cervix

Fecha de inicio: 1 de junio de 1999

DISEASE CHARACTERISTICS: Histologically confirmed stage IVB, recurrent, or persistent carcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiotherapy Eligible subtypes: Squamous cell carcinoma Adenosquamous carcinoma Adenocarcinoma Measurable disease by physical examination, radiography, CT scan, or MRI Measurable disease by CT scan/MRI without biopsy confirmation allowed if lesions are at least 3 cm and well defined No craniospinal metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL No bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage Other: Not pregnant or nursing Fertile patients must use effective contraception No clinically significant infection No other prior invasive malignancy within the past 5 years except nonmelanoma skin cancer Body surface area no greater than 2.0 m^2 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior chemoradiotherapy and recovered No prior chemotherapy except when used concurrently with radiotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy At least 3 weeks since prior radiotherapy only and recovered Surgery: Recovered from prior surgery Other: No prior anticancer treatment that would preclude study therapy