The aging of society and the resultant increased numbers of older cancer patients has made the study of this expanding population a priority. Traditionally, older cancer patients have been excluded from clinical trials. The reasons are multiple but include fear of toxicity, low institutional priority, restrictive inclusion criteria, social support and funding issues. The result has been that there is very little prospective data to make evidence-based decisions. This makes the elderly an underserved population with many unmet needs. This is particularly true of patients over 80 years of age for whom virtually no data exists. To date, there have been few studies that have shown a significant difference in the pharmacokinetics between the ‘typical’ patients and the elderly. Pharmacokinetic differences, when present, have not been clinically relevant. This lack of data mandates trials specific for the elderly. Suggestions for clinical trial design are presented.