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A Study of Gemcitabine, Cisplatin, and 5-Fluorouracil in the Treatment of Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Study of Gemcitabine, Cisplatin, and 5-Fluorouracil in the Treatment of Advanced Pancreatic Cancer

OBJECTIVES: I. Determine the overall survival in patients with unresectable stage III or IV
pancreatic adenocarcinoma treated with gemcitabine, cisplatin, and fluorouracil. II.
Determine the resectability rate with curative intent in patients with unresectable stage
III pancreatic adenocarcinoma treated with this regimen. III. Assess the tolerability and
toxicity of this treatment regimen in this patient population. IV. Evaluate this regimen in
terms of response rate, response duration, and overall time to disease progression in these
patients. V. Evaluate the quality of life in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, followed by
cisplatin IV over 30 minutes on days 1 and 15. Patients receive fluorouracil as a continuous
infusion on days 1-15. Courses repeat every 28 days. Quality of life is assessed every 28

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic
adenocarcinoma Unresectable locally advanced (stage III) OR Metastatic (stage IV)
Gallbladder or biliary tract cancer allowed No endocrine tumors or lymphoma of the
pancreas No CNS metastases

PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Life expectancy: At least
12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than
3.0 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Other: No
active infection No other serious systemic disorders No other active malignancies within
the past year except curatively treated basal cell skin cancer or carcinoma in situ of the
cervix Must have central venous access device (i.e., Infusaport or PASPORT) Not pregnant
or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for locally advanced or metastatic disease At least 6 months since prior
adjuvant chemotherapy No prior gemcitabine Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Philip A. Philip, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

August 2003

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms



Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201