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

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Biochemical Modulation Dihydropyrimidine Dehydrogenase Oral Administration Pharmacokinetics

Description

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.

Attachments

readout_NCT00001579_2024-07-14.pdf

4.5 MB

NCT00001579_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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