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Modulation of 5-Fluorouracil With Trimetrexate and Leucovorin in Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Modulation of 5-Fluorouracil With Trimetrexate and Leucovorin in Advanced Pancreatic Cancer

OBJECTIVES: I. Evaluate tumor response to a trimetrexate, fluorouracil and leucovorin
regimen in patients with advanced pancreatic carcinoma. II. Evaluate the toxicities
associated with this regimen in patients with metastatic carcinoma of the pancreas.

OUTLINE: The treatment plan consists of an IV infusion of trimetrexate, followed 24 hours
later by IV infusions of leucovorin and fluorouracil. After another 24 hours oral leucovorin
will be given every 6 hours for 7 doses. A treatment cycle consists of the regimen repeated
weekly for 6 weeks followed by 2 weeks of rest. Treatment cycles will be repeated until
disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: If 3 or more complete or partial responses are observed in the first 22
patients, an additional 11 patients may be accrued for a maximum of 33.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced pancreatic cancer with metastatic
disease Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte
count at least 1,500/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0
mg/dL SGOT, SGPT and alkaline phosphatase less than 3 times upper limit of normal Serum
albumin at least 3.0 g/dL Renal: Serum creatinine no greater than 1.5 mg/dL Other: Not
eligible for higher priority protocol No prior malignancy within 5 years except adequately
treated basal cell carcinoma of the skin or carcinoma in situ of the cervix Not pregnant
or nursing Fertile patients must use effective birth control No underlying medical
condition precluding treatment

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or
concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent
radiotherapy No prior radiotherapy to only site(s) of measurable disease Fully recovered
from therapy Surgery: Fully recovered from prior surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Agustin Garcia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:

CDR0000065428 (3P-95-1)



Start Date:

August 1995

Completion Date:

June 2006

Related Keywords:

  • Pancreatic Cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800