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Armstrong, A.J. et al.

Andrew J. Armstrong, Patricia Creel, James Turnbull, Cassandra Moore, Tracy A. Jaffe, Sherri Haley, William Petros, Sarah Yenser, Jon P. Gockerman, Darryl Sleep, Herbert Hurwitz, Daniel J. George,

A phase I-II study of docetaxel and atrasentan in men with castration-resistant metastatic prostate cancer.

PURPOSE: The primary aims of this phase I-II study were to determine the maximum tolerated dose, dose-limiting toxicity, pharmacokinetics, and preliminary efficacy of the combination of docetaxel and the endothelin A receptor antagonist atrasentan as first-line treatment for men with metastatic castration-resistant prostate cancer. EXPERIMENTAL DESIGN: Patients were treated with docetaxel at doses ranging from 60 to 75 mg/m(2) every 21 days, with daily oral atrasentan 10 mg starting on day 3. Patients were treated until evidence of disease progression or unacceptable toxicity. RESULTS: Thirty-one patients were enrolled over three docetaxel dose levels (8 at 60 mg/m(2), 19 at 70 mg/m(2), and 4 at 75 mg/m(2)) including dose expansion at 70 mg/m(2). The maximum tolerated dose of docetaxel was 70 to 75 mg/m(2). Drug-related grade 3-4 toxicities included neutropenia (50-63%) and febrile neutropenia (16-25%); other grade 1-2 toxicities included fatigue, peripheral edema, diarrhea, headache, rhinitis, anorexia, and nausea. Confirmed prostate-specific antigen (PSA) responses were observed in 23% [95% confidence interval (95% CI), 10-41%]; the rate of >30% declines in PSA was 35% (95% CI, 19-55%). Median overall survival was 17.6 months (95% CI, 13.0-23.2) and median progression-free survival was 4.2 months (95% CI, 2.3-5.8). Significant declines in bone alkaline phosphatase and serum N-telopeptides were observed with therapy. CONCLUSIONS: The maximum tolerated dose of every-3-week docetaxel with 10 mg atrasentan is 70 to 75 mg/m(2). Overall survival and progression-free survival are comparable to that seen with docetaxel and prednisone, whereas the rates of PSA decline are slightly lower than expected. A phase III study of this combination with prednisone has been initiated and is ongoing.[1]

References

A phase I-II study of docetaxel and atrasentan in men with castration-resistant metastatic prostate cancer. Armstrong, A.J., Creel, P., Turnbull, J., Moore, C., Jaffe, T.A., Haley, S., Petros, W., Yenser, S., Gockerman, J.P., Sleep, D., Hurwitz, H., George, D.J. Clin. Cancer Res. (2008) [Pubmed]

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