Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00268411|
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : December 22, 2005
Last Update Posted : May 27, 2008
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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.
PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: gemcitabine hydrochloride Drug: oxaliplatin||Phase 3|
- Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.
- Compare the clinical benefits and tolerability of these regimens in these patients.
- Compare the progression-free and overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.
In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Official Title:||Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]|
|Study Start Date :||September 2004|
- Objective response rate
- Clinical benefits and tolerability
- Progression-free and overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268411
|Avignon, France, 84902|
|Beauvais, France, 60021|
|Dijon, France, 21000|
|Centre Hospitalier de Dreux|
|Dreux, France, 28100|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, F-85025|
|Hopital Saint - Louis|
|La Rochelle, France, 17000|
|Hopital Louis Pasteur - Le Coudray|
|Le Coudray, France, 28630|
|Clinique Victor Hugo|
|Le Mans, France, F-72000|
|Polyclinique des Quatre Pavillons|
|Lormont, France, 33310|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Senlis, France, 60309|
|Study Chair:||Christophe Louvet, MD, PhD||Hopital Saint Antoine|