Pharmacy Medical News about advanced solid tumors;fixed-dose docetaxel;irinotecan;estramustine phosphate

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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.

Methods

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.

Results

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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