Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lecia V. Sequist
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Bristol-Myers Squibb; Dana-Farber Cancer Institute; St. Joseph Hospital Health Center; Unity Health Toronto
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC

• Patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the EGFR pathway

• Measurable disease, as defined by RECIST criteria

• Patients must have a suitable frozen or paraffin-embedded tissue sample available for EGFR mutational analysis. Prior EGFR mutational analyses are allowable

• Patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable

• ECOG Performance Status 0-2

• 18 years of age or older

• Negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential

• Bone marrow function, renal function, hepatic function as outlined in protocol

Exclusion Criteria:

• Women who are pregnant of breastfeeding

• Active concurrent malignancy

• Major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab

• Significant history of uncontrolled cardiac disease

• Uncontrolled seizure disorder, or active neurological disease

• Prior severe infusion reactions to a monoclonal antibody

• Prior chemotherapy regimen within 21 days prior to study entry

• Any EGFR tyrosine kinase inhibitor within 14 days of study entry

• Radiation therapy within 14 days prior to the first infusion of cetuximab

• Acute hepatitis or known HIV

• Active or uncontrolled infection

• Any concurrent chemotherapy or any other investigational agent(s)