Estramustine in combination with vinblastine and mitomycin-C for patients with progressive androgen independent adenocarcinoma of the prostate

A phase II trial was performed to assess the antitumor activity and toxicit y of estramustine in combination with vinblastine and mitomycin-C in 46 con secutive patients with androgen independent prostate cancer. All patients p resented with disease progression following castrate serum testosterone lev els and were treated for six consecutive weeks with three daily 140 mg dose s of oral estramustine, vinblastine at 5 mg/m(2) weekly by intravenous bolu s and mitomycin-C at 15 mg/m(2) every six weeks by intravenous bolus. Prostate specific antigen levels decreased by greater than 50% from baselin e in 16 (41%; 95% CI 25-58%) and normalized in 11 (28%; 95% CI 14-45%) of 3 9 evaluable patients. Patients who demonstrated a greater than 50% reductio n in PSA had a longer delay in time to disease progression. Non-hematologic toxicity was mild, predominately gastrointestinal. Hematologic toxicity wa s apparent in five patients with Grade III granulocytopenia and in 21 patie nts with Grade IV granulocytopenia of 43 evaluable patients for toxicity. T hree patients were admitted to the hospital for neutropenic fever. Eight pa tients had Grade III thrombocytopenia, four patients had Grade IV thrombocy topenia, no bleeding occurred. Estramustine in combination with vinblastine and mitomycin-C is an active regimen. The non-hematologic toxicity was tol erable, while the hematologic toxicity required individual dosage reduction . The combination and the clinical significance of the decline in the PSA w arrants further investigation.