Integrated Molecular Profiling in Advanced Cancers Trial

The increasing appreciation and identification of specific somatic mutations and other genetic aberrations that drive cancers leave us on the threshold of a new era of "personalized cancer medicine", in which specific biomarkers will be used to direct targeted agents only to those patients deemed most likely to respond. The potential medical, scientific and economic benefits of such a personalized approach to cancer therapy are immense and self-evident. Yet despite some important advances, only a limited number of approved targeted agents have had their approvals predicated on specific biomarkers of sensitivity or resistance.

The premises behind personalized cancer medicine include: i) genetic aberrations exist in human malignancies; ii) a subset of these aberrations, often present across multiple cancer types, have functional relevance as "hallmarks" or "drivers" for oncogenesis and tumor progression; iii) such genetic aberrations are potentially "druggable" targets; and iv) there are tolerable medicinal compounds that can effectively modulate such targets. A key requirement of this new, personalized approach to anti-cancer therapy is that specific patients must be matched to a particular drug or combination of drugs. Molecular profiling of tumors to identify somatic mutations and/or other genetic aberrations are examples of enrichment strategies to assist in matching patients to drugs or treatments that have gained increasing interest in the oncology community.

The present protocol seeks to provide molecular profiling data to the treating physician for patients with advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas, as well as patients who are phase I trial candidates, in order to help identify which standard regimens or clinical trials of molecularly targeted therapies may be most appropriate for the individual patient.

Inclusion criteria

• Patients with histological confirmation of advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas who are candidates for systemic therapy, as well as patients who are phase I trial candidates.
• Patient must be ≥ 18 years old.
• Patient's ECOG performance status equal to 0 or 1.
• All patients must have signed and dated an informed consent form.
• All patients must have sufficient archived tumor tissue for molecular profiling.

Exclusion criteria

• None