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A phase I/II trial of fixed-dose docetaxel plus irinotecan and escalating doses of estramustine phosphate for second-line or greater treatment of selected advanced solid tumors
Anti-Cancer Drugs, 07/02/09

Baz W et al. - In a study to evaluate the safety and efficacy of combination irinotecan, docetaxel, and estramustine for selected advanced solid tumors, it was concluded that estramustine in combination with docetaxel and irinotecan is a well-tolerated regimen with minimal hematologic toxicity, mild to moderate nonhematologic toxicity, and promising initial antitumor activity in previously treated pts with advanced solid tumors.

• 22 pts were enrolled.
• The regimen consisted of docetaxel 30 mg/m2 and irinotecan 60 mg/m2 both given intravenously on days 1 and 8 every 21 days in combination with escalating doses of estramustine (500 mg/m2/day escalated to 750 mg/m2/day on days 0, 1, 2, 7, 8, and 9 given every 21 days) during phase I.
• Dose escalation was continued until maximum planned dose level of estramustine (750 mg/m2/day) was reached.
• After the appropriate phase II dose of estramustine was found, additional pts were enrolled.

• 21 of 22 pts were evaluable for toxicity and 17 for tumor response.
• Recommended phase II dose of estramustine was 750 mg/m2/day orally on days 0, 1, 2, 7, 8, and 9 given every 21 days.
• Hematologic toxicity was fairly mild, with only 1 episode of grade 3 neutropenia.
• Diarrhea was the most common nonhematologic toxicity with grade 3 toxicity occurring in 5 of 21 pts.
• Only 1 episode of venous thrombosis was observed.
• Objective response rate was 15.8%, overall clinical benefit rate was 63%, and median time to progression was 15 wks.

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