Combination Chemotherapy In Treating Patients With Advanced Cancer Of The Pancreas

Study Overview

Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas

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.

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.

Pancreatic Cancer

DRUG: fluorouracil
DRUG: leucovorin calcium
DRUG: trimetrexate glucuronate

CDR0000065428 (3P-95-1)
LAC-USC-3P951
NCI-G97-1173

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 1999-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-05-20
First Submitted that Met QC Criteria 2004-08-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-05-22
First Posted (ESTIMATED) 2004-08-12	Results First Posted N/A	Last Verified 2014-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Agustin Garcia, MD, University of Southern California

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Garcia AA, Leichman L, Baranda J, et al.: Phase II study of trimetrexate (neutrexin), 5-fluorouracil and leucovorin (NFL) in advacne pancreatic. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A971, 253a, 1999.

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Resources

PatientS

Caregivers

Clinical Trial Record