Stage IV Non-small Cell Lung Cancer Clinical Trial
Official title:
A Pharmacogenetic and Pharmacodynamic Study of Erlotinib (OSI-774) Toxicity in Patients With Advanced Solid Tumors
This phase I/II trial is studying the side effects of erlotinib and to see how well it works in treating patients with metastatic or unresectable non-small cell lung cancer, ovarian cancer, or squamous cell carcinoma (cancer) of the head and neck. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
PRIMARY OBJECTIVES:
I. To determine if a significant correlation exists between the length of the CA
dinucleotide repeat polymorphism in the EGFR gene and observed toxicity in patients treated
with OSI-774.
SECONDARY OBJECTIVES:
I. To study the pharmacodynamic effects of OSI-774 on EGFR activity and MAP kinase signaling
using skin as a surrogate tissue.
II. To determine if interindividual variation of OSI-774 pharmacokinetics is related to a
previously described CYP3A5 genetic polymorphism.
III. To evaluate whether toxicity or inhibition of EGFR phosphorylation correlates with
OSI-774 AUC in patients treated with OSI-774.
IV. To describe the observed anti-tumor response and toxicities in patients with advanced
solid tumors treated with single agent fixed dose of OSI-774.
OUTLINE: This is a multicenter study. Patients are stratified according to length of CA
dinucleotide repeat polymorphism (short vs medium vs long).
Patients receive oral erlotinib on days 1-28. Courses repeat every 28 days in the absence of
disease progression or unacceptable toxicity.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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