Spots Global Cancer Trial Database for Cetuximab in Treating Patients With Advanced Solid Tumors

Study Description

Brief Summary: RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase I trial is studying the side effects and best dose of cetuximab in treating patients with advanced solid tumors.

Detailed Description: OBJECTIVES: Primary * Determine the maximum tolerated dose of cetuximab in patients with advanced solid tumors. Secondary * Evaluate the safety and tolerability of this drug in these patients. * Develop a detailed scale for assessment of rash in these patients. * Investigate potential predictors of response using correlative studies on patient tissue, buccal mucosa, and blood samples. * Obtain preliminary efficacy data and evaluate the relationship of efficacy to grade of rash. * Correlate downstream markers (e.g., pMAPK, pAKT, and Ki-67) and the presence of epidermal growth factor receptor (EGFR) polymorphisms with clinical response and/or survival. * Examine the levels of downstream marker proteins in buccal cells obtained pre- and post-treatment. * Correlate basal p27 expression levels with response and/or survival. * Determine if the presence of a K-RAS mutation influences response or survival outcome. * Correlate the presence or absence of mutant K-RAS tumor DNA shed into patient plasma with response and/or outcome. * Correlate levels of cytokines and chemokines with rash and clinical response. OUTLINE: This is an open-label, dose-escalation study. Patients receive cetuximab IV over 90 minutes once weekly for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cetuximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD. Patients undergo blood and buccal mucosa collection at baseline and prior to courses 2 and 3 of treatment for molecular correlative studies. Archival tumor tissue specimens are also used for molecular correlative studies. Immunologic correlative studies are performed using patient blood samples. After completion of study treatment, patients are followed periodically for survival. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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