Modulation of 5-Fluorouracil With Trimetrexate and Leucovorin in Advanced Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
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:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Agustin Garcia, MD
Investigator Role:
Study Chair
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000065428 (3P-95-1)
NCT ID:
NCT00002955
Start Date:
August 1995
Completion Date:
June 2006
Related Keywords:
- Pancreatic Cancer
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
