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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00599833
First received: January 11, 2008
Last updated: June 25, 2013
Last verified: August 2009
  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
Biological: cetuximab
Radiation: 3-dimensional conformal radiation therapy
Phase 2

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

Resource links provided by NLM:


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
Study Completion Date: October 2010
Primary Completion Date: September 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
Christie Hospital NHS Foundation Trust
Investigators
Study Chair: Pat Price, MD Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00599833     History of Changes
Other Study ID Numbers: CHNT-PACER, CDR0000582420, EUDRACT-2006-001742-13, EU-207103, CTA-21266/0210/001-0001
Study First Received: January 11, 2008
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014