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

Lecia V. Sequist

Status and phase

Terminated

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Cetuximab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00694603

06-026

Details and patient eligibility

About

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.

Full description

Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects.
The following will be performed every 4 weeks while they are receiving study treatments: Physical examination; performance status; and blood work. A CT scan of the chest and upper abdomen will be performed every 8 weeks.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)