Combination Chemobiotherapy With Gemcitabine, 5-Fluorouracil, Interleukin-2 and Alpha Interferon in Patients With Metastatic or Unresectable Renal Cell Cancer. A Phase II Study

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable carcinoma of the
kidney No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy:
Greater than 4 months Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least
2,500/mm3 Platelet count at least 100,000/mm3 PT no greater than 1.3 times upper limit of
normal (ULN) Hematocrit at least 28% Hepatic: Bilirubin less than 2.0 mg/dL SGOT no
greater than 1.25 times ULN (unless due to tumor) Renal: Creatinine less than 2.0 mg/dL
Calcium less than 12 mg/dL Proteinuria no greater than 2.0 by dipstick Cardiovascular: No
active angina No uncontrolled congestive heart failure No uncontrolled arrhythmias No
myocardial infarction within 6 months Pulmonary: No significant pulmonary disease (RA pO2
less than 60 or pCO2 greater than 50) Other: Not pregnant or nursing Fertile patients must
use effective contraception HIV negative No active infection No daily emesis or inability
to tolerate solid foods No prior or concurrent second malignancy within 2 years, except:
Nonmelanoma skin cancer Carcinoma in situ of the cervix No sever diarrhea (greater than 4
watery stools per day) No active pelvic inflammatory disease No inflammatory bowel disease
No uncontrolled seizure disorders No personal or family history of malignant hyperthermia
No recent thromboembolism or any condition requiring concurrent anticoagulation

PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent biologic therapy
Chemotherapy: No prior gemcitabine No prior fluorouracil other than adjuvant fluorouracil
received at least 1 year prior to study No other concurrent chemotherapy Endocrine
therapy: Concurrent corticosteroids not allowed (except for nausea or vomiting)
Radiotherapy: At least 14 days since prior radiation to axial skeleton No concurrent
radiotherapy (except to local lesions) Surgery: At least 14 days since prior exploration
and biopsy At least 21 days since prior resection with anastomosis No major organ
allograft Other: No concurrent barbiturates No concurrent oral anticoagulants No other
concurrent investigational drugs or devices