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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
cetuximab
3-dimensional conformal radiation therapy
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cookridge Hospital
  • Christie Hospital

Outcomes

Primary Outcome Measures

Progression-free survival rate at 6 months

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2008
Last Updated
June 25, 2013
Sponsor
The Christie NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00599833
Brief Title
Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
Official Title
Locally Advanced Pancreatic Cancer: Phase II Study of Cetuximab and 3-D Conformal Image Guided Radiotherapy (PACER)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage III pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Type
Radiation
Intervention Name(s)
3-dimensional conformal radiation therapy
Primary Outcome Measure Information:
Title
Progression-free survival rate at 6 months
Secondary Outcome Measure Information:
Title
Response rate by RECIST criteria
Title
Toxicity by NCI CTCAE criteria
Title
Clinical benefit response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pat Price, MD
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

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

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