Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct
|ClinicalTrials.gov Identifier: NCT00010088|
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : May 20, 2004
Last Update Posted : February 9, 2009
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 combining gemcitabine, leucovorin, and fluorouracil in treating patients who have locally advanced or metastatic cancer of the pancreas or bile duct.
|Condition or disease||Intervention/treatment||Phase|
|Extrahepatic Bile Duct Cancer Pancreatic Cancer||Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine the response rate, in terms of WHO objectives and clinical benefit, in patients with locally advanced or metastatic pancreatic or biliary adenocarcinoma treated with gemcitabine, leucovorin calcium, and fluorouracil. II. Determine the tolerance of this regimen in this patient population. III. Determine the survival without disease progression in patients treated with this regimen. IV. Determine the overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours on day 1 followed by gemcitabine IV over 80-150 minutes on day 2. Treatment repeats every 2 weeks for a minimum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response may continue chemotherapy for up to 1 year. Patients with locally advanced disease after 3 months of chemotherapy may receive concurrent radiotherapy with chemotherapy for 5 weeks, or may undergo surgical resection. Fluorouracil-based chemotherapy (with or without radiotherapy) may then resume after surgery. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas|
|Study Start Date :||January 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010088
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|Study Chair:||Christophe Louvet, MD, PhD||Hopital Saint Antoine|