Phase II Study Of Neoadjuvant Chemotherapy In Borderline Resectable Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00728000|
Recruitment Status : Withdrawn (study withdrawn due to lack of enrollment)
First Posted : August 5, 2008
Last Update Posted : April 27, 2009
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Adenocarcinoma||Drug: Gemcitabine Drug: Oxaliplatin Drug: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||August 2009|
|Estimated Study Completion Date :||August 2010|
Experimental: chemotherapy regimen
Gemcitabine and oxaliplatin are given intravenously (into the vein) every 2 weeks. Erlotinib is a pill that is taken by mouth daily.
Gemcitabine 1000mg/m2 IV on day 1 and day 15 over 30mins.
Other Name: Gemzar®Drug: Oxaliplatin
100mg/m2 IV on days 1 and 15 given over 120 mins.
Other Name: EloxatinDrug: Erlotinib
100mg/day PO on days 1-14 and 15-28
Other Name: Tarceva
- The primary endpoint is a dichotomous variable evaluating the # of patients who obtain an RO resection versus the number of patients that do not obtain an RO resection plus the number of patients who are not resectable. [ Time Frame: 9-10 months ]
- DFS, PFS, OS and TD will be observed on each patient and censored at the end of the study. Measurements of toxicity are categorical variables. All numerical variables will be summarized by mean +- standard deviation (STD) and/or median (range) [ Time Frame: 9-10 months ]
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): NCT00728000
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Leslie Oleksowicz, MD||University of Cincinnati|