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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), March 2008

Sponsored by: Christie Hospital
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00599833
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: cetuximab
Procedure: 3-dimensional conformal radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Cetuximab    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival rate at 6 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity by NCI CTCAE criteria [ Designated as safety issue: Yes ]
  • Clinical benefit response [ Designated as safety issue: No ]

Estimated Enrollment:   44
Study Start Date:   May 2007
Estimated Primary Completion Date:   May 2012 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599833

Locations
United Kingdom, England
Christie Hospital     Recruiting
      Manchester, England, United Kingdom, M20 4BX
      Contact: Contact Person     44-161-446-8003        
Cookridge Hospital     Recruiting
      Leeds, England, United Kingdom, LS16 6QB
      Contact: Contact Person     44-113-392-4475     adrian.crellin@leedsth.nhs.uk    

Sponsors and Collaborators
Christie Hospital

Investigators
Study Chair:     Pat Price, MD     Christie Hospital    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000582420, CHNT-PACER, EUDRACT-2006-001742-13, EU-207103, CTA-21266/0210/001-0001
First Received:   January 11, 2008
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00599833
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas  
stage III pancreatic cancer  

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Cetuximab
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008




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