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Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas or Bile Duct

This study is ongoing, but not recruiting participants.

Sponsored by: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00010088
  Purpose

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 Intervention Phase
Extrahepatic Bile Duct Cancer
Pancreatic Cancer
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: leucovorin calcium
Procedure: conventional surgery
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Leucovorin Calcium    Citrovorum factor    Folinic acid calcium salt pentahydrate    Leucovorin    Gemcitabine hydrochloride    Gemcitabine    Fluorouracil    Calcium gluconate    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   January 1999

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed pancreatic or biliary duct adenocarcinoma Metastatic or locally advanced No cerebral metastasis Surgically unresectable

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: More than 12 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Alkaline phosphatase less than 5 times normal Bilirubin less than 1.5 times normal Renal: Creatinine less than 1.5 times normal No uncontrolled or persistent hypercalcemia Cardiovascular: No severe cardiac failure Pulmonary: No severe respiratory failure Other: No other malignant tumor considered incurable or untreatable No uncontrolled pain No psychological, familial, social, or geographical reasons that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids except as antiemetic Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010088

Show 50 study locations  Show 50 Study Locations

Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators
Study Chair:     Christophe Louvet, MD, PhD     Hopital Saint Antoine    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:

Study ID Numbers:   CDR0000068440, FRE-GERCOR-FOLFUGEM2-D99-3, EU-20024
First Received:   February 2, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00010088
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer  
stage III pancreatic cancer  
unresectable extrahepatic bile duct cancer  
adenocarcinoma of the extrahepatic bile duct
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Bile duct cancer, extrahepatic
Digestive System Neoplasms
Biliary Tract Neoplasms
Pancreatic Neoplasms
Leucovorin
Endocrine System Diseases
Pancrelipase
Carcinoma
Digestive System Diseases
Bile Duct Diseases
Fluorouracil
Biliary Tract Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Bile Duct Neoplasms
Gemcitabine
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Vitamins
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on October 10, 2008




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