In vitro studies and early clinical trials suggest that estramustine plus taxol is an active combination that needs further investigation. One of the major drawbacks with this regimen has been the long-term infusion of taxol and side effects. Several studies suggest that the infusion period can be reduced, toxicities diminished and efficacy maintained. Based on the response to shorter taxol infusions observed with breast and ovarian cancer, it appears justified to assess whether a similar response can be achieved in prostate cancer. In this context, a one-hour, weekly infusion of taxol may be equally or more effective than longer infusions. Similarly, higher doses and shorter courses of estramustine may decrease side effects without impairing synergistic activity. Treatment will be given three days per week for six weeks. Estramustine (900 mg/m2/day) will be given orally in three divided doses days 1-3 (the two days prior to and on the day of taxol administration). Taxol (starting dose 40 mg/m2) will be administered as a weekly one-hour infusion on day 3. There will be five increments in the taxol dose, provided grade III or IV toxicity is not observed: 60 mg/m2, 75 mg/m2, 90 mg/m2, 100 mg/m2, 110 mg/m2, until a maximum tolerated dose (MTD) is reached. If equally effective, this new schedule of administration has the potential of decreasing undesirable side effects, facilitating administration in the office setting and minimizing costs.
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