Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
OBJECTIVES:
Primary
- Compare the objective response rate in patients with metastatic adenocarcinoma of the
pancreas treated with two different schedules of gemcitabine hydrochloride and
oxaliplatin.
Secondary
- Compare the clinical benefits and tolerability of these regimens in these patients.
- Compare the progression-free and overall survival of patients treated with these
regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the
participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and
oxaliplatin IV over 2 hours on day 2.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by
oxaliplatin IV over 2 hours on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
- Measurable disease (primary tumor or metastasis)
- At least 1 cm in diameter by spiral CT scan
- No ampulla of Vater carcinoma or biliary adenocarcinoma
- No known brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Life expectancy more than 12 weeks
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Alkaline phosphatase < 5 times normal
- Bilirubin < 1.5 times normal
- Creatinine < 1.5 times normal
- No pre-existing neuropathy
- No unstable or uncontrolled pain
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No serious cardiovascular disease
- No serious respiratory disease
- No uncontrolled or persistent hypercalcemia
- No psychological, familial, social, or geographical condition that would preclude
study treatment
- No other active malignancy
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No concurrent corticosteroids
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Objective response rate
Safety Issue:
No
Principal Investigator
Christophe Louvet, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Saint Antoine
Authority:
United States: Federal Government
Study ID:
CDR0000453849
NCT ID:
NCT00268411
Start Date:
September 2004
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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