RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with advanced cancer of the pancreas.

Condition	Treatment or Intervention	Phase
stage IVA pancreatic cancer stage IVB pancreatic cancer	Drug: fluorouracil  Drug: leucovorin calcium  Drug: trimetrexate glucuronate	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven advanced pancreatic cancer with metastatic disease
• Bidimensionally measurable disease

--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

--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

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

Study chairs or principal investigators

Agustin Garcia,  Study Chair,  University of Southern California   

Study ID Numbers:  CDR0000065428; LAC-USC-3P951; NCI-G97-1173
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002955
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08