Overcoming Age-Dependent Barriers to Early Phase Trials

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DESCRIPTION (provided by applicant) This proposal is in response to the RFA CA-03-501 entitled "Overcoming Barriers to Early Phase Clinical Trials" to be conducted at the NCI-designated University of Colorado Comprehensive Cancer Center (UCCC). The focus of this proposal is to identify and develop methods to minimize age-dependent barriers to enrollment on early-phase clinical trials in oncology. With the increasing numbers of mechanism-based therapies undergoing clinical development, it is becoming more difficult to enroll the older or younger-aged patients due to the intensity of the early-phase trials that often incorporate multiple biological, clinical and pharmacological endpoints. Likewise, community-based oncology practices experience difficulty referring these patients due to the lack of adequate infrastructure to provide the patients with transportation; to maintain frequent follow-up visits; to handle and process research specimens; and to transmit data. The two barriers approached in this proposal are centered around the adolescent/ young adult and geriatric patient populations. Although related, each barrier incorporates an initial survey tool to assess what the perceived barriers are from each patient population in addition to preliminary strategies to facilitate and maintain community referral and participation in the early-phase trials. Outcomes assessments have been included with the intent of redirecting accrual strategies according to interim results of surveys. Collateral benefits that may be expected from enhancing accrual of the older and younger patient in early clinical trials include: 1) refinement of dosing strategies and improved tolerability with new agents, 2) earlier participation and thus enhanced familiarity of community oncologists with new agents, and 3) broader age representation in biological and pharmacological specimens. The ultimate goals of this proposal are to formulate strategies for overcoming age-dependent barriers that may be exported to other Cancer Centers; and to form the basis for further work in age-dependent barriers to clinical trial participation.