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Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

Phase 2
18 Years
75 Years
Open (Enrolling)
Extrahepatic Bile Duct Cancer, Pancreatic Cancer

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Trial Information

Study Of Gemcitabine, Leukovorin, And Fluorouracil Used To Treat Locally Advanced And Metastatic Pancreatic And Biliary Adenocarcinomas

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.

Inclusion Criteria

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Christophe Louvet, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Saint Antoine


United States: Federal Government

Study ID:




Start Date:

January 1999

Completion Date:

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Pancreatic Cancer
  • 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
  • Adenocarcinoma
  • Pancreatic Neoplasms
  • Bile Duct Neoplasms