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

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Anti Cancer Agents Antimetabolite Palliation Pharmacodynamics Pharmacokinetics

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).

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.

Attachments

readout_NCT00001449_2024-07-23.pdf

4.5 MB

NCT00001449_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

5 stars
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4 stars
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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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