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


Phase 1
N/A
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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


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).

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

950197

NCT ID:

NCT00001449

Start Date:

September 1995

Completion Date:

April 2000

Related Keywords:

  • Neoplasms
  • Anti-Cancer Agents
  • Antimetabolite
  • Palliation
  • Pharmacodynamics
  • Pharmacokinetics
  • Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892