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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00001449
Enrollment
60
Registered
2002-12-10
Start date
1995-09-30
Completion date
2000-04-30
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Anti-Cancer Agents, Antimetabolite, Palliation, Pharmacodynamics, Pharmacokinetics

Brief summary

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.

Detailed description

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).

Interventions

DRUGgemcitabine
DRUGfluorodeoxyuridine
DRUGleucovorin

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026