UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed solid tumor that is metastatic or unresectable and for which no standard curative or palliative measures exist or are effective
• •No brain metastases or primary CNS malignancy
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Absolute neutrophil count at least 1,500/mm3
• •Platelet count at least 100,000/mm3
• •Hepatic
• •Bilirubin no greater than 1.5 mg/dL
• •AST and ALT no greater than 3 times upper limit of normal
• •Renal
• •Creatinine no greater than 1.5 mg/dL OR
• •Creatinine clearance at least 60 mL/min
• •Cardiovascular
• •No known active coronary artery disease
• •Pulmonary
• •No pulmonary dysfunction
• •Other
• •HIV negative
• •No history of unusually severe and/or prolonged toxicity during prior therapy with fluorouracil (5-FU) or 5-FU prodrugs
• •No diabetes mellitus requiring insulin or oral hypoglycemic therapy
• •No ongoing or active infection requiring IV antibiotics
• •No other serious concurrent medical illness that would preclude study
• •No psychiatric illness or social situations that would preclude study
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •At least 4 weeks since prior immunotherapy and recovered
• •No concurrent cytokines during the first course of therapy
• •Chemotherapy
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• •Endocrine therapy
• •No concurrent systemic corticosteroids
• •Radiotherapy
• •At least 2 weeks since prior radiotherapy and recovered
• •No prior pulmonary or mediastinal radiation exceeding 40 Gy
• •Surgery
• •Recovered from prior surgery
• •Other
• •No other concurrent investigational agents
• •No concurrent cimetidine
• •No concurrent sorivudine or brivudine