Status:
UNKNOWN
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giv...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00268411
Start Date
September 1 2004
Last Update
May 27 2008
Active Locations (15)
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1
Hopital Duffaut
Avignon, France, 84902
2
C.H.G. Beauvais
Beauvais, France, 60021
3
Hopital Drevon
Dijon, France, 21000
4
Centre Hospitalier de Dreux
Dreux, France, 28100