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

NCT ID: NCT00599833

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-10-31

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.

Conditions

Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cetuximab

Intervention Type: BIOLOGICAL

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Christie NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

Pat Price, MD

Role: STUDY_CHAIR

The Christie NHS Foundation Trust

Locations

Cookridge Hospital

Leeds, England, United Kingdom

Christie Hospital

Manchester, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CDR0000582420

Identifier Type: REGISTRY

Identifier Source: secondary_id

EUDRACT-2006-001742-13

Identifier Type: -

Identifier Source: secondary_id

EU-207103

Identifier Type: -

Identifier Source: secondary_id

CTA-21266/0210/001-0001

Identifier Type: -

Identifier Source: secondary_id

CHNT-PACER

Identifier Type: -

Identifier Source: org_study_id