Cancer is a disease of aging, and the majority of cancers occur in persons over 65 years of age. In spite of this, few elders have been represented in clinical trials, and the need for information regarding the treatment of elders with cancer remains great. Recognizing these needs, the Cancer and Leukemia Group B (CALGB) formed an elderly Working Group in 1995, and after initial success in developing clinical studies focused on elders, a Cancer in the Elderly Committee. The Committee's objective is to focus attention on issues specifically relevant to the treatment of cancer in the older patient. Two strategies were developed to achieve this objective: (a) to initiate projects and protocols within the Committee and (b) to foster the initiation of studies by other CALGB committees. The research themes of the Committee and the main thrust of committee's research activities are (a) understanding and overcoming barriers to clinical trials participation; (b) treatment efficacy and pharmacokinetic/pharmacologic issues related to chemotherapy and hormone therapy in the older cancer patient; and (c) improving the quality of life for older cancer patients. The Cancer in the Elderly Committee has been successful in developing, implementing, and completing trials in all these areas and serves as a major resource for clinical trials development for the CALGB.