Cetuximab, Radiotherapy And Twice Weekly Gemcitabine To Treat Pancreatic Cancer

Study Overview

Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

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

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

Pancreatic Cancer

DRUG: Cetuximab/Gemcitabine
PROCEDURE: Radiotherapy

DMS 0432

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2005-09-22	Results First Submitted 2012-08-22	Last Update Submitted that met QC Criteria 2014-07-10
First Submitted that Met QC Criteria 2005-09-22	Results First Submitted that Met QC Criteria 2013-04-16	Last Update Posted (ESTIMATED) 2014-07-16
First Posted (ESTIMATED) 2005-09-26	Results First Posted 2013-04-18	Last Verified 2011-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cetuximab, Gemcitabine, RT weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy	DRUG: Cetuximab/Gemcitabine Once weekly Cetuximab, twice weekly Gemcitabine for six weeks PROCEDURE: Radiotherapy Daily radiotherapy for 28 days

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Cetuximab, Gemcitabine, RT

weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy

DRUG: Cetuximab/Gemcitabine

Once weekly Cetuximab, twice weekly Gemcitabine for six weeks

PROCEDURE: Radiotherapy

Daily radiotherapy for 28 days

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: J Marc Pipas, MD, Dartmouth-Hitchcock Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record