Pancreatic Neoplasms
Conditions
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
Interventions
DRUGOxaliplatin
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate based on RECIST criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression | — |
| Overall survival | — |
| Clinical benefit | — |
| Quality of life | — |
Countries
South Korea
Outcome results
None listed