Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Cetuximab/Gemcitabine; Procedure: Radiotherapy

• Registration Number: NCT00225784
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-26
• Primary Completion: 2010-02
• Status Verified: 2011-10
• Results First Submitted: 2012-08-22
• Study Completion: 2012-09
• Results First Submitted QC: 2013-04-16
• Results First Posted: 2013-04-18
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cetuximab, Gemcitabine, RT	Radiotherapy	weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
Cetuximab, Gemcitabine, RT	Cetuximab/Gemcitabine	weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy

Primary Outcome Measures

Name	Time	Method
Objective Response of Tumor by RECIST 1.0 Criteria	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Assessed for Adverse Events	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	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.	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	Five years post treatment	Time to disease progression after therapy.
Overall Length of Survival After Therapy	Five years post treatment	Length of survival after therapy in all participants enrolled.
Pattern of Failure After Therapy	Five years post treatment	Local recurrence, distant recurrence, or both.