The purpose of this study is to determine the clinical toxicities associated with
administering sequential dFdC as a one hour infusion followed by a continuous infusion of
FUdR over 24 hours with low dose oral LV weekly for three weeks out of four.
The MTD and biochemically active dose of FUDR as a 24-hour and gemcitabine as a 2-hour
infusion will be determined first (Part A); if the biochemically active FUDR dose is less
than the MTD, new patients will be entered to determine the maximum tolerated duration of
FUDR infusion (Part B).
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.