Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
OBJECTIVES:
Primary
- Compare the overall survival of patients with locally advanced or metastatic
unresectable pancreatic adenocarcinoma treated with gemcitabine with or without
oxaliplatin.
Secondary
- Compare the time of response in patients treated with these regimens.
- Compare the clinical benefit of and tolerance to these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally
advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and
9-11 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV
over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence
of disease progression or unacceptable toxicity.
After the completion of chemotherapy, patients with locally advanced disease receive
chemoradiotherapy.
Quality of life is assessed at baseline and then every 2 months.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
study within 24 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed pancreatic adenocarcinoma
- Locally advanced or metastatic disease
- Unresectable disease
- Measurable disease
- At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
- No adenocarcinoma of the bile ducts or ampulla of Vater
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 75
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 12 weeks
Hematopoietic
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- Bilirubin less than 1.5 times normal
- Alkaline phosphatase less than 5 times normal
Renal
- Creatinine less than 1.5 times normal
- No uncontrolled or persistent hypercalcemia
Cardiovascular
- No serious cardiac failure
Pulmonary
- No serious respiratory failure
Other
- Pain must be stabilized or controlled before initiation of study treatment
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other untreatable malignant tumor
- No serious psychological, familial, social, or geographical condition that would
preclude study participation
- No neuropathy that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- No concurrent corticosteroids except for antiemetic therapy
Radiotherapy
- No prior radiotherapy
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Christophe Louvet, MD, PhD
Investigator Affiliation:
Hopital Saint Antoine
Authority:
United States: Federal Government
Study ID:
CDR0000346480
NCT ID:
NCT00075452
Start Date:
November 2003
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage II pancreatic cancer
- stage III pancreatic cancer
- stage IV pancreatic cancer
- Adenocarcinoma
- Pancreatic Neoplasms
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