Clinical Trials and Translational Applications in Cancer Therapy
Despite the gains that had been made in increasing overall survival and extending disease-free survival rates, cancer is still one of the leading causes of death in the United States . There remains an urgent need for the rapid development of new cancer therapeutics. Unfortunately, only about 5% of new compounds intended for use in cancer therapy are approved for clinical use . The time and enormous costs involved in conducting clinical trials are special barriers to drug development [3, 4]. Careful thought regarding each phase of investigation is critical for the successful and efficient completion and interpretation of a clinical trial and prior to widespread clinical use of a new drug. This chapter focuses on clinical trials in oncology and translational applications. The global objectives of cancer clinical trials are to evaluate promising, new agents that may alleviate symptoms and/or cure the disease. As newer agents such as molecular targeted therapies are developed, questions remain as to whether current models of clinical trial design are sufficient. Nevertheless, classic design forms the basis of drug development in cancer therapy. Study objectives and endpoints are associated with specific study designs and determine the level of testing and the number of subjects required for each phase (Fig. 1) .
KeywordsEpidermal Growth Factor Receptor Maximal Tolerable Dose Epidermal Growth Factor Receptor Mutation Clinical Trial Design Randomize Control Clinical Trial
- 6.FDA, Food and Drug Administration. 2008. http://www.fda.gov/oc/gcp/.
- 14.Booth CM, Calvert AH, Giaccone G, Lobbezoo MW, Seymour LK, Eisenhauer EA. Endpoints and other considerations in phase I studies of targeted anticancer therapy: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT). Eur J Cancer 2008; 44: 19–24.PubMedCrossRefGoogle Scholar
- 20.Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205–216.PubMedCrossRefGoogle Scholar
- 27.Morris GJ, Naidu S, Topham AK, Guiles F, Xu Y, McCue P, Schwartz GF, et al. Differences in breast carcinoma characteristics in newly diagnosed African-American and Caucasian patients: a single-institution compilation compared with the National Cancer Institute's Surveillance, Epidemiology, and End Results database. Cancer 2007; 110: 876–884.PubMedCrossRefGoogle Scholar
- 28.Khabele D. Racial and ethnic health disparities, women and cancer. The Medscape Journal 2005. http://cme.medscape.com/viewprogram/4412.