Status:
COMPLETED
GEMOX: Oxaliplatin in Pancreatic Cancer
Lead Sponsor:
Sanofi
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Primary objective: * To evaluate overall response rate (based on RECIST criterion) Secondary objective: * To evaluate time to progression, clinical benefit, quality of life and safety
Eligibility Criteria
Inclusion
- Histologically proven adenocarcinoma of the pancreas
- Metastatic or locally advanced, non resectable disease(Non resectable disease will be determined by the investigators with clinical data)
- Uni-dimensionally measurable disease as defined by RECIST (primary or secondary tumors\>2cm using conventional CT scan or ≥1cm with spiral CT scan)
- No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant therapy for non-target lesion is permitted
- Karnofsky Performance Status (KPS) ≥60
- No known Central Nervous System metastases
- No sensory neuropathy at inclusion
- Biological and hematological evaluation \< 2 weeks prior to treatment administration:
- Neutrophils ≥ 1500/ mm3
- Platelets ≥ 100,000/mm3
- Alkaline phosphatases\< 5X ULN(upper Limits of Normal) and Bilirubin \< 1.5X ULN
- SGOT,SGPT \<2.5 X ULN if no liver metastasis
- SGOT,SGPT \<5 X ULN if liver metastasis
- Creatinine \< 1.5 X ULN
- Baseline imaging (CT scan or Magnetic Resonance Imaging) \<3 weeks before treatment administration
- Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
Exclusion
- Corticotherapy except for anti-emetic purpose
- Pregnant or breast feeding women (Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs)
- Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
- Uncontrolled or persistent hypercalcemia
- History of significant neurologic or psychiatric disorders
- Vater ampulomas and biliary tract adenocarcinomas
- Other -non cured- malignancies
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00261092
Start Date
October 1 2005
Last Update
April 15 2008
Active Locations (1)
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1
Sanofi-Aventis
Seoul, South Korea