Details

Autor(en) / Beteiligte

• KELLY, William Kevin
• CURLEY, Tracy
• GEORGE, Daniel
• OH, William
• SMITH, Matthew
• KAUFMAN, Donald
• SMALL, Eric J
• SCHWARTZ, Lawrence
• LARSON, Steve
• TONG, William
• SCHER, Howard
• SLOVIN, Susan
• HELLER, Glenn
• MCCAFFREY, John
• BAJORIN, Dean
• CIOLINO, Allison
• REGAN, Kevin
• SCHWARTZ, Morton
• KANTOFF, Philip

Titel

Paclitaxel, Estramustine Phosphate, and Carboplatin in Patients With Advanced Prostate Cancer

Ist Teil von

• Journal of clinical oncology, 2001-01, Vol.19 (1), p.44-53

Ort / Verlag

Baltimore, MD: American Society of Clinical Oncology

Erscheinungsjahr

2001

Quelle

MEDLINE

Beschreibungen/Notizen

• To determine the safety and activity of weekly paclitaxel in combination with estramustine and carboplatin (TEC) in patients with advanced prostate cancer. In a dose-escalation study, patients with advanced prostate cancer were administered paclitaxel (weekly 1-hour infusions of 60 to 100 mg/m(2)), oral estramustine (10 mg/kg), and carboplatin (area under the curve, 6 mg/mL-min every 4 weeks). Paclitaxel levels were determined 0, 30, 60, 90, and 120 minutes and 18 hours after infusion, and a concentration-time curve was estimated. Once a safe dose was established, a multi-institutional phase II trial was conducted in patients with progressive androgen-independent disease. Fifty-six patients with progressive androgen-independent disease were treated for a median of four cycles. The dose of paclitaxel was escalated from 60 to 100 mg/m(2) without the occurrence of DLT. Posttherapy decreases in serum prostate-specific antigen levels of 50%, 80%, and 90% were seen in 67%, 48%, and 39% (95% confidence interval, 55% to 79%, 35% to 61%, 26% to 52%) of the patients, respectively. Of the 33 patients with measurable disease, two (6%) had a complete response and 13 (39%) had a partial response. The overall median time to progression was 21 weeks, and the median survival time for all patients was 19.9 months. Major grade 3 or 4 adverse effects were thromboembolic disease (in 25% of patients), hyperglycemia (in 38%), and hypophosphatemia (in 42%). Significant leukopenia, thrombocytopenia, and peripheral neuropathy were not observed. TEC has significant antitumor activity and is well tolerated in patients with progressive androgen-independent prostate cancer.