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Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Phase 2
18 Years
75 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer

OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced
or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin. II.
Determine the tolerablility and clinical benefit of this regimen in these patients. III.
Evaluate the progression free survival and the overall survival of these patients when
treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on day 1 over 1.5
hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the
absence of disease progression or unacceptable toxicity. Patients with locally advanced
disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or locally
advanced unresectable adenocarcinoma of the pancreas Measurable disease At least 2 cm in
diameter No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 OR Karnofsky 60-100%
Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times
upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal:
Creatinine no greater than 1.5 times ULN Cardiovascular: Adequate cardiac function
Pulmonary: Adequate respiratory function Other: Not pregnant or nursing Fertile patients
must use effective contraception No sensitive neuropathy No other active malignancy No
uncontrolled hypercalcemia No significant medical or psychiatric condition that would
preclude study No psychological, familial, sociological, or geographical condition that
would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior
chemotherapy Endocrine therapy: No concurrent corticosteroid use except as antiemetic
Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent
investigational drugs

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:

September 1999

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms