Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
First received: September 22, 2005
Last updated: April 16, 2013
Last verified: October 2011
This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Dartmouth-Hitchcock Medical Center:
Primary Outcome Measures:
- Objective Response of Tumor by RECIST 1.0 Criteria [ Time Frame: one month post-therapy ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Number of Participants Assessed for Adverse Events [ Time Frame: Participants were followed during treatment and for 30 days after completion of treatment ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Time to disease progression after therapy.
- Overall Length of Survival After Therapy [ Time Frame: Five years post treatment ] [ Designated as safety issue: No ]Length of survival after therapy in all participants enrolled.
- Pattern of Failure After Therapy [ Time Frame: Five years post treatment ] [ Designated as safety issue: No ]Local recurrence, distant recurrence, or both.
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
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
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
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