A Phase II study of estramustine, docetaxel, and carboplatin with granulocyte–colony‐stimulating factor support in patients with hormone‐refractory prostate carcinoma

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Abstract
BACKGROUND The authors determined the safety and efficacy of estramustine, docetaxel, and carboplatin with granulocyte–colony‐stimulating factor (G‐CSF) support in patients with hormone‐refractory prostate carcinoma. METHODS In the current multicenter, cooperative group study, patients with advanced prostate carcinoma whose disease progressed despite androgen deprivation therapy were treated with a combination of oral estramustine(240 mg three times per day for 5 days), 70 mg/m2 of docetaxel, and carboplatin at a dose of (area under the curve) 5. G‐CSF was used to minimize the neutropenia associated with this regimen. Each cycle was repeated every 21 days. RESULTS Forty patients were treated with a median of 7 cycles of therapy. Of the 34 evaluable patients with elevated pretreatment prostate‐specific antigen (PSA) levels, 23 (68%) had a ≥ 50% decline in PSA and 20 (59%) had a ≥ 75% decline. Twenty‐one patients had measurable disease, with 1 complete response (5%) and 10 partial responses (47%), for an overall measurable response rate of 52% (95% confidence interval [95% CI], 30–74%). The most common Grade 3 or Grade 4 toxicities (according to the National Cancer Institute Common Toxicity Criteria) included neutropenia in 23% of patients, thrombocytopenia in 13%, and fatigue in 13%. Febrile neutropenia occurred in 1 patient (3%). The overall median time to disease progression was 8.1 months (95% CI, 6–10 months) and the overall survival period was 19 months (95% CI, 13–26 months). CONCLUSIONS The combination of estramustine, docetaxel, and carboplatin with G‐CSF support was found to have significant clinical activity with an acceptable toxicity profile in patients with progressive hormone‐refractory prostate carcinoma. Cancer 2003;98:2592–8. © 2003 American Cancer Society.