Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00225784|
Recruitment Status : Completed
First Posted : September 26, 2005
Results First Posted : April 18, 2013
Last Update Posted : July 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Cetuximab/Gemcitabine Procedure: Radiotherapy||Phase 2|
The study treatment for this protocol is
- Loading dose of Cetuximab 400 mg/m2
- Weekly Cetuximab 250 mg/m2
- Bi-weekly Gemcitabine 50 mg/m2
- Daily Radiation for 28 fractions
- CT scan four weeks after completion of treatment
- Evaluation by surgeon for resectability
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||September 2012|
Experimental: Cetuximab, Gemcitabine, RT
weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
Other Name: ErbituxProcedure: Radiotherapy
Daily radiotherapy for 28 days
- Objective Response of Tumor by RECIST 1.0 Criteria [ Time Frame: one month post-therapy ]Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.
- Number of Participants Assessed for Adverse Events [ Time Frame: Participants were followed during treatment and for 30 days after completion of treatment ]Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0
- Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy [ Time Frame: 1 month after completion of treatment ]Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).
- Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment. [ Time Frame: One month post-therapy ]Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.
- Disease-Free Survival After Therapy [ Time Frame: Five years post treatment ]Time to disease progression after therapy.
- Overall Length of Survival After Therapy [ Time Frame: Five years post treatment ]Length of survival after therapy in all participants enrolled.
- Pattern of Failure After Therapy [ Time Frame: Five years post treatment ]Local recurrence, distant recurrence, or both.
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): NCT00225784
|Principal Investigator:||J Marc Pipas, MD||Dartmouth-Hitchcock Medical Center|