Clinical trial NCT00694603: Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy
Official title: A Phase II Trial of Cetuximab (c225) as Therapy for Recurrent Non-Small Cell Lung Cancer in Patients Who Have Received Prior Therapy With Tyrosine Kinase Inhibitor Directed Against the EGFR Pathway
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: cetuximab
tyrosine kinase inhibitor
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: Unity Health Toronto
name: Bristol-Myers Squibb
First posted: 2008-06-10
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Response Rate by CT Scan Using RECIST Criteria
timeFrame: 8 weeks
Secondary outcomes:
measure: Progression-free Survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lecia Sequist, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neal JW, Heist RS, Fidias P, Temel JS, Huberman M, Marcoux JP, Muzikansky A, Lynch TJ, Sequist LV. Cetuximab monotherapy in patients with advanced non-small cell lung cancer after prior epidermal growth factor receptor tyrosine kinase inhibitor therapy. J Thorac Oncol. 2010 Nov;5(11):1855-8. doi: 10.1097/JTO.0b013e3181f0bee0.