A Phase I Study of Weekly Gemcitabine in Combination With Infusional Fluorodeoxyuridine and Oral Calcium Leucovorin in Adult Cancer Patients

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • 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.
• PRIOR/CONCURRENT THERAPY:
• • Biologic Therapy: Greater than 4 weeks since prior immunotherapy and recovered from all toxic effects.
• • 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.
• PATIENT CHARACTERISTICS:
• • Age: 18 and over.
• • Performance status: ECOG 0-2
• Hematopoietic:
• • 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.
• OTHER:
• • No failure of prior gemcitabine therapy.
• • No concurrent cimetidine (ranitidine and other anti-ulcer agents allowed).
• • No active infection requiring intravenous antibiotic therapy.
• • HIV negative.
• • No other medical contraindication to protocol therapy.
• • No pregnant or nursing women.
• • Adequate contraception required of fertile patients.