Paclitaxel (Taxol) combination therapy for resistant germ cell tumors.

Rob Paclitaxel (Taxol; Bristol-Myers Squibb Company Princeton, NJ) showed antitumor activity in patients with germ cell tumors resistant to combination cisplatin-containing chemotherapy and was included in two risk-directed first-line combination salvage programs. Patients with relapsed germ cell tumors originating from a testis primary site were treated in a phase I/II trial with conventional-dose paclitaxel, ifosfamide, and cisplatin. Fifteen of 21 evaluable patients (71%) achieved a complete or partial response with normal serum tumor markers; 12 patients (57%) remain progression free with a median follow-up period of 15 months. Accrual to this trial continues to further define efficacy and toxicity. In a second trial, patient with cisplatin-resistant germ cell tumors and unfavorable prognostic features (prior incomplete response or an extragonadal primary site) were treated with a dose-intensive program consisting of rapid recycling of paclitaxel plus ifosfamide followed by carboplatin plus etoposide with stem cell support. Twenty-one of 37 assessable patients (57%) achieved a complete response and two (5%) achieved a partial response with negative serum tumor markers; 15 (41%) of these patients remain in durable response with a median follow-up period of 30 months.