A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced, persistent, or recurrent squamous
cell carcinoma of the cervix that failed local therapy and is considered incurable
Bidimensionally measurable abdominal, pelvic, or other lesion by palpation, x- ray, or
ultrasound If sole site of measurable disease previously irradiated, then documented
disease progression at that site required

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Karnofsky 60%-100%
Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count
at least 100,000/mm3 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 1.4 mg/dL Creatinine clearance at least 50 mL/min if creatinine greater
than 1.2 mg/dL Other: No clinically significant infection No preexisting, clinically
significant peripheral neuropathy unless due to cancer No other prior or concurrent
malignancy except nonmelanomatous skin cancer No psychological, familial, sociological, or
geographical condition that would preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy except for radiosensitization Endocrine therapy: Not specified Radiotherapy:
See Chemotherapy Recovered from the toxic effects of any recent radiotherapy Surgery:
Recovered from the toxic effects of any recent surgery