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

NCT00599833 | Completed Phase 2

• 5 other identifiers: CHNT-PACERCDR0000582420EUDRACT-2006-001742-13EU-207103CTA-21266/0210/001-0001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage III pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate at 6 months

Secondary Outcomes (3)

• Response rate by RECIST criteria

• Toxicity by NCI CTCAE criteria

• Clinical benefit response

Interventions

cetuximab BIOLOGICAL

3-dimensional conformal radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (2)

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cetuximab; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Pat Price, MD

  The Christie NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: May 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 26, 2013

Record last verified: 2009-08

Locations

GB (2)