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
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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