Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
|ClinicalTrials.gov Identifier: NCT00006117|
Recruitment Status : Unknown
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 22, 2004
Last Update Posted : October 30, 2009
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine and oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: gemcitabine hydrochloride Drug: oxaliplatin||Phase 2|
OBJECTIVES: I. Determine the objective tumor response rate in patients with locally advanced or metastatic pancreatic carcinoma when treated with gemcitabine and oxaliplatin. II. Determine the tolerablility and clinical benefit of this regimen in these patients. III. Evaluate the progression free survival and the overall survival of these patients when treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive gemcitabine IV on day 1 over 1.5 hours and oxaliplatin IV over 2 hours on day 2. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with locally advanced disease receive 6-8 courses and then may undergo surgery, radiotherapy, and/or additional chemotherapy.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Gemcitabine Plus Oxaliplatin in Patients With Locally Advanced or Metastatic Pancreatic Cancer|
|Study Start Date :||September 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006117
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier Victor Dupouy|
|Argenteuil, France, 95107|
|Clichy, France, 92118|
|Dijon, France, 21000|
|Clinique Saint Jean|
|Lyon, France, 69008|
|American Hospital of Paris|
|Neuilly Sur Seine, France, F-92202|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75970|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Study Chair:||Christophe Louvet, MD, PhD||Hopital Saint Antoine|