Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Los Angeles, California 90095


RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. PURPOSE: This phase II trial is studying how well cetuximab works in treating patients with recurrent or progressive metastatic non-small cell lung cancer.

Study summary:

OBJECTIVES: Primary - Determine whether expression of Calgranulin B, E-Cadherin, S100P, FXYD domain containing 3, Cathepsin B, and/or Serpin E2 can predict response to cetuximab in patients with recurrent or progressive metastatic non-small cell lung cancer. Secondary - Determine whether additional genes can be identified, using microarray analysis and panels of candidate genes for involvement in cancer, that are predictive of response to this drug in these patients. - Determine whether proteins discovered in serum can predict tumor response to this drug in these patients. - Correlate CA repeats, single nucleotide polymorphisms, or mutations of genes within the epidermal growth factor receptor pathway with response to this drug in these patients. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients receive cetuximab IV over 1-2 hours once weekly for 8 weeks. Courses repeat every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for at least 30 days, every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.


DISEASE CHARACTERISTICS: - Histologically confirmed non-small cell lung cancer - Metastatic disease - Recurrent or progressive disease - Tumor must be accessible to biopsy or fine needle aspiration - Unidimensionally measurable disease - Received ≥ 1 prior platinum-based combination chemotherapy regimen for recurrent or progressive disease - Asymptomatic brain metastasis allowed provided patient completed radiotherapy and/or radiosurgery ≥ 3 weeks ago AND is off steroids PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8 g/dL Hepatic - AST and ALT ≤ 2.5 times upper limit of normal (ULN) - Bilirubin ≤ 1.5 times ULN - Alkaline phosphatase ≤ 2.5 times ULN - PT and/or INR ≤ 10% above ULN Renal - Creatinine ≤ 2 mg/dL OR - Creatinine clearance ≥ 50 mL/min Cardiovascular - No uncontrolled hypertension - No unstable angina - No congestive heart failure - No uncontrolled arrhythmia - No other significant cardiac disease Neurologic - No uncontrolled seizure disorder - No active neurological disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective double-barrier contraception during and for ≥ 4 weeks after completion of study treatment - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - Not a prisoner - Not compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness PRIOR CONCURRENT THERAPY: Biologic therapy - No prior antibody therapy that targets the epidermal growth factor receptor (EGFR) Chemotherapy - See Disease Characteristics - More than 30 days since prior chemotherapy Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - More than 3 weeks since prior radiotherapy - No prior radiotherapy to the only site of measurable disease unless there is documented disease progression after radiotherapy - Prior local radiotherapy for the management of tumor-related symptoms allowed Surgery - More than 30 days since prior major thoracic or abdominal surgery and recovered Other - Prior therapy with EGFR tyrosine kinase inhibitors allowed - More than 30 days since prior investigational agents



Primary Contact:

Principal Investigator
Fairooz F. Kabbinavar, MD
Jonsson Comprehensive Cancer Center

Backup Contact:


Location Contact:

Los Angeles, California 90095
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.