Cetuximab And Radiation Therapy In Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

Study Overview

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

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.

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.

Pancreatic Cancer

BIOLOGICAL: cetuximab
RADIATION: 3-dimensional conformal radiation therapy

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

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 2008-01-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-25
First Submitted that Met QC Criteria 2008-01-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-26
First Posted (ESTIMATED) 2008-01-24	Results First Posted N/A	Last Verified 2009-08

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:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Progression-free survival rate at 6 months

Secondary Outcome Measures	Measure Description	Time Frame
Response rate by RECIST criteria
Toxicity by NCI CTCAE criteria
Clinical benefit response

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:

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

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

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

Collaborators and Investigators

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

Investigators

STUDY_CHAIR: Pat Price, MD, The Christie NHS Foundation Trust

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

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Caregivers

Clinical Trial Record