Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

July 10, 2014 updated by: Dartmouth-Hitchcock Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
Other Names:
  • Erbitux
Procedure: Radiotherapy
Daily radiotherapy for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one month post-therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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).
1 month after completion of treatment
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.
One month post-therapy
Disease-Free Survival After Therapy
Time Frame: Five years post treatment
Time to disease progression after therapy.
Five years post treatment
Overall Length of Survival After Therapy
Time Frame: Five years post treatment
Length of survival after therapy in all participants enrolled.
Five years post treatment
Pattern of Failure After Therapy
Time Frame: Five years post treatment
Local recurrence, distant recurrence, or both.
Five years post treatment

Collaborators and Investigators

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

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: J Marc Pipas, MD, Dartmouth-Hitchcock Medical Center

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 Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

September 22, 2005

First Submitted That Met QC Criteria

September 22, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DMS 0432

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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