Expired Study
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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: March 16, 2018

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