Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

June 25, 2013 updated by: The Christie NHS Foundation Trust

Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cetuximab together with 3-dimensional conformal radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with radiation therapy works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • To evaluate the progression free survival rate in patients treated with cetuximab and radiotherapy.

Secondary

  • To determine the response rate, toxicity of the combined regimen, and clinical benefit response in patients treated with cetuximab and radiotherapy.

OUTLINE: Patients receive cetuximab IV over 1-2 hours once weekly for 6-7 weeks. Patients also undergo concurrent 3-dimensional image-guided conformal radiotherapy in 28-30 fractions over approximately 5.5-6 weeks (2-4 hours after administration of cetuximab).

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United Kingdom
    • England
      • Leeds, England, United Kingdom, LS16 6QB
        • Cookridge Hospital
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital

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

DISEASE CHARACTERISTICS:

  • Histopathologically or cytologically confirmed diagnosis of inoperable, non-metastatic, locally advanced pancreatic adenocarcinoma
  • No neuroendocrine tumors or lymphoma of the pancreas
  • No extensive disease unable to be covered in a radically treatable radiotherapy volume

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 60-100%
  • Life expectancy > 3 months
  • Hemoglobin ≥ 10g/dL
  • WBC ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³ (prior transfusions for patients with low hemoglobin allowed)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN
  • Serum urea ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Adequate biliary drainage with no evidence of active uncontrolled infection (patients on prophylactic antibiotics are eligible)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Women and men of child-bearing potential should be using an adequate contraception method, which must be continued for 3 months after completion of therapy
  • No unresolved biliary tract obstruction

  • No history of prior malignancy that may interfere with the response evaluation except for any of the following:

    • Cervical carcinoma in-situ treated by cone-biopsy/resection
    • Nonmetastatic basal and/or squamous cell carcinomas of the skin
    • Any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously
  • No relative contraindication to radiotherapy
  • No evidence of severe uncontrolled systemic diseases or laboratory finding that in the view of investigator makes it undesirable for the patient to participate in the trial
  • No disorder likely to impact compliance with the protocol

PRIOR CONCURRENT THERAPY:

  • Must be completely recovered from previous surgery

  • The following prior interventions are allowed:

    • Non-curative operation (i.e., R2 resection with macroscopic residual disease evident on CT scan or palliative bypass procedure)
    • Stent insertion in the common bile duct
  • No previous radiotherapy within current treatment field
  • No previous administration of EGF monoclonal antibodies, EGFR signal transduction inhibitors or EGFR-targeted therapy

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival rate at 6 months

Secondary Outcome Measures

Outcome Measure
Clinical benefit response
Response rate by RECIST criteria
Toxicity by NCI CTCAE criteria

Collaborators and Investigators

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

Sponsor

The Christie NHS Foundation Trust

Investigators

  • Study Chair: Pat Price, MD, The Christie NHS Foundation Trust

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

May 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 11, 2008

First Submitted That Met QC Criteria

January 11, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHNT-PACER
  • CDR0000582420 (Registry Identifier: PDQ (Physician Data Query))
  • EUDRACT-2006-001742-13
  • EU-207103
  • CTA-21266/0210/001-0001

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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