Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

Study Overview
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Brief Summary
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This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.

Detailed Description
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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

Official Title
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A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Cetuximab/Gemcitabine
* Procedure: Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic proof of pancreatic adenocarcinoma Clinical stage I, II, or III disease Radiographically measurable disease Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry Signed protocol consent Karnofsky performance status of at least 70% Age > or = to 18 years Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment. Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul. Creatinine < 1.5 x upper limit of normal (ULN) Bilirubin < 1.5 x ULN; AST < 2.5 x ULN. Exclusion Criteria: Acute hepatitis or known HIV Active or uncontrolled infection Significant history of cardiac disease Prior therapy which affects or targets the EGF pathway Prior severe infusion reaction to a monoclonal antibody Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents Any previous chemotherapy or abdominal or pelvic radiotherapy No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years. Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetuximab, Gemcitabine, RT<br>weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy | Drug: Cetuximab/Gemcitabine<br>* Once weekly Cetuximab, twice weekly Gemcitabine for six weeks<br>* Other names: Erbitux;Procedure: Radiotherapy<br>* Daily radiotherapy for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response of Tumor by RECIST 1.0 Criteria | 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. | one month post-therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Assessed for Adverse Events | Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0 | Participants were followed during treatment and for 30 days after completion of treatment | 
| Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy | 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). | 1 month after completion of treatment | 
| Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment. | Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment. | One month post-therapy | 
| Disease-Free Survival After Therapy | Time to disease progression after therapy. | Five years post treatment | 
| Overall Length of Survival After Therapy | Length of survival after therapy in all participants enrolled. | Five years post treatment | 
| Pattern of Failure After Therapy | Local recurrence, distant recurrence, or both. | Five years post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage I, II, III pancreatic adenocarcinoma, Radiographically measurable disease