Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2005-10-31
Brief Summary
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* To evaluate overall response rate (based on RECIST criterion)
Secondary objective:
* To evaluate time to progression, clinical benefit, quality of life and safety
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Oxaliplatin
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Principal Investigators
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Won-Sik Lee, MD
Role: STUDY_DIRECTOR
sanofi-avents
Locations
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Sanofi-Aventis
Seoul, , South Korea
Countries
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Other Identifiers
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PM_L_0126
Identifier Type: -
Identifier Source: org_study_id