Recurrent Colon Cancer Clinical Trial
Official title:
A Phase I Evaluation of Cetuximab and RAD001 in Patients With Solid Tumors
This phase I trial studies the side effects and best dose of cetuximab when given together with everolimus in treating patients with metastatic or recurrent colon cancer or head and neck cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of the tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cetuximab together with everolimus may be an effective treatment for colon cancer or head and neck cancer
PRIMARY OBJECTIVES:
I. Determine the safety, dose-limiting toxicity and maximum tolerated dose of daily RAD001
(everolimus) when given in combination with a fixed dose of weekly cetuximab in patients
with solid tumors.
SECONDARY OBJECTIVES:
I. Determine whether a pharmacokinetic interaction exists between RAD001 and CETUXIMAB in
patients treated with this regimen.
II. Determine preliminary clinical evidence of anti-tumor activity by time to progression
and Response Evaluation Criteria in Solid Tumors (RECIST) criteria with this regimen.
III. Determine the association between clinical outcomes and biologic markers that may
predict sensitivity of a tumor in patients treated with this regimen.
IV. Determine the pharmacodynamic effects of this regimen on post-therapy tumor and/or skin
specimens.
OUTLINE: This is a dose-escalation study of everolimus.
Patients receive everolimus orally (PO) once daily (QD) on days -14 and then 1-28. Patients
also receive cetuximab intravenously (IV) over 60-120 minutes on days -7 and then once
weekly beginning on day 1. Courses repeat every 28 days in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 2 months for at least 1
year.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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