Search / Trial NCT00001579

A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors

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

Trial Information

Current as of December 09, 2024

Completed

Keywords

Biochemical Modulation Dihydropyrimidine Dehydrogenase Oral Administration Pharmacokinetics

ClinConnect Summary

The primary purpose of this Phase I protocol is to develop an orally administered regimen of fluorouracil (5-FU) given with fixed doses of leucovorin (LV) and 776C85 (GW776), a mechanism-based inhibitor of dihydropyrimidine dehydrogenase (DPD), the rate-limiting enzyme involved in the catabolism of 5-FU. In the presence of 776C85, 5-FU is cleared by renal mechanisms. The schedule employed is intended to mimic the pharmacologic profile associated with a 24 hour weekly continuous infusion of 5-FU without the need for an indwelling central venous catheter. The target population is adult cancer...

Gender

ALL

Eligibility criteria

  • DISEASE CHARACTERISTICS:
  • Histologically proven solid tumor that has failed standard therapy or for which no such therapy exists.
  • Tumor may be locally advanced and unresectable, recurrent and/or metastatic.
  • Lymphomas with minimal or no involvement of bone marrow are also eligible.
  • No primary malignancies or metastatic disease of the CNS.
  • No symptomatic pre-existing peripheral neuropathy.
  • PRIOR/CURRENT THERAPY:
  • BIOLOGIC THERAPY:
  • No immunotherapy within past 4 weeks.
  • Recovered from toxic effects.
  • CHEMOTHERAPY:
  • No chemotherapy within past 4 weeks (6 weeks for nitrosoureas).
  • No mitomycin within past 12 weeks.
  • Recovered from toxic effects.
  • ENDOCRINE THERAPY: Not specified.
  • RADIOTHERAPY:
  • No radiotherapy within past 2 weeks (8 weeks for strontium therapy).
  • Recovered from toxic effects.
  • SURGERY: Recovered from prior surgery.
  • OTHER: No concurrent cimetidine.
  • PATIENT CHARACTERISTICS:
  • AGE: 18 and over.
  • PERFORMANCE STATUS: ECOG 0-2.
  • LIFE EXPECTANCY: Not specified.
  • HEMATOPOIETIC:
  • Absolute granulocyte count at least 2000/mm(3);
  • Platelet count at least 100,000/mm(3).
  • HEPATIC:
  • Bilirubin no greater than 2 times upper normal limit;
  • SGOT/SGPT no greater than 4 times upper normal limit.
  • RENAL:
  • Creatinine no greater than 1.6 mg/dL;
  • Creatinine clearance greater than 55 mL/min.
  • OTHER:
  • Not pregnant or nursing.
  • Fertile patients must use effective contraception.
  • Not HIV positive.
  • No active infections requiring intravenous antibiotic therapy.
  • No other serious concurrent illness.
  • No evidence of hemolytic uremic syndrome.

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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