Search / Trial NCT00001449

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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Anti Cancer Agents Antimetabolite Palliation Pharmacodynamics Pharmacokinetics

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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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