GEMOX: Oxaliplatin in Pancreatic Cancer

Study Overview
=================
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

Official Title
-----------------
Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer

Conditions
-----------------
Pancreatic Neoplasms

Intervention / Treatment
-----------------
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate based on RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Overall survival |  |  | 
| Clinical benefit |  |  | 
| Quality of life |  |  |