Combination Chemotherapy in Treating Patients With Advanced Cancer of the Pancreas
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|ClinicalTrials.gov Identifier: NCT00002955|
Recruitment Status : Completed
First Posted : August 12, 2004
Last Update Posted : May 22, 2014
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 or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: fluorouracil Drug: leucovorin calcium Drug: trimetrexate glucuronate||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Official Title:||Modulation of 5-Fluorouracil With Trimetrexate and Leucovorin in Advanced Pancreatic Cancer|
|Study Start Date :||August 1995|
|Actual Primary Completion Date :||May 2000|
|Actual Study Completion Date :||June 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002955
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033-0800|
|Study Chair:||Agustin Garcia, MD||University of Southern California|