A Phase I Study of Weekly Gemcitabine in Combination With Infusional Fluorodeoxyuridine and Oral Calcium Leucovorin in Adult Cancer Patients
Diagnostically proven locally advanced, but unresectable primary or recurrent solid tumors
or lymphoma or metastatic solid tumors that have failed standard therapy or no such
therapy is available.
Objectively measurable disease not required.
No patients with leukemia or primary or metastatic CNS malignancies.
Biologic Therapy: Greater than 4 weeks since prior immunotherapy and recovered from all
Chemotherapy: Greater than 4 weeks since prior chemotherapy and recovered from all toxic
effects with following exceptions: At least 6 weeks since prior mitomycin C or nitrosourea
therapy. At least 3 months since prior suramin therapy.
Endocrine Therapy: Not specified
Radiotherapy: At least 2 weeks since prior radiotherapy (4 weeks if at least 21% of
marrow irradiated) and recovered from all toxic effects.
Surgery: Recovered from any prior surgery.
Age: 18 and over.
Performance status: ECOG 0-2
AGC at least 2,000/microL.
Platelet count at least 100,000/microL.
Hepatic: Bilirubin no greater than 2.0 mg/dL.
Renal: Creatinine no greater than 2.0 mg/dL.
No failure of prior gemcitabine therapy.
No concurrent cimetidine (ranitidine and other anti-ulcer agents allowed).
No active infection requiring intravenous antibiotic therapy.
No other medical contraindication to protocol therapy.
No pregnant or nursing women.
Adequate contraception required of fertile patients.