Paclitaxel, estramustine phosphate, and carboplatin in patients with advanced prostate cancer Journal Article

Authors: Kelly, W. K.; Curley, T.; Slovin, S.; Heller, G.; McCaffrey, J.; Bajorin, D.; Ciolino, A.; Regan, K.; Schwartz, M.; Kantoff, P.; George, D.; Oh, W.; Smith, M.; Kaufman, D.; Small, E. J.; Schwartz, L.; Larson, S.; Tong, W.; Scher, H.
Article Title: Paclitaxel, estramustine phosphate, and carboplatin in patients with advanced prostate cancer
Abstract: Purpose: To determine the safety and activity of weekly paclitaxel in combination with estramustine and carboplatin (TEC) in patients with advanced prostate cancer. Patients and Methods: In a dose-escalation study, patients with advanced prostate cancer were administered paclitaxel (weekly 1-hour infusions of 60 to 100 mg/m2), 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. Results: 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/m2 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. Conclusion: TEC has significant antitumor activity and is well tolerated in patients with progressive androgen-independent prostate cancer. © 2001 by American Society of Clinical Oncology.
Keywords: adult; cancer survival; human tissue; aged; aged, 80 and over; middle aged; survival rate; major clinical study; clinical trial; drug tolerability; advanced cancer; area under the curve; dose response; drug safety; paclitaxel; prostate specific antigen; carboplatin; phase 2 clinical trial; etoposide; leukopenia; thrombocytopenia; antineoplastic combined chemotherapy protocols; peripheral neuropathy; antineoplastic activity; dose-response relationship, drug; docetaxel; prostate cancer; prostate-specific antigen; prostatic neoplasms; survival time; multicenter study; drug clearance; drug blood level; neoplasms, hormone-dependent; estramustine; estramustine phosphate; humans; human; male; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 19
Issue: 1
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2001-01-01
Start Page: 44
End Page: 53
Language: English
PUBMED: 11134194
PROVIDER: scopus
DOI: 10.1200/JCO.2001.19.1.44
Notes: Export Date: 21 May 2015 -- Source: Scopus
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MSK Authors
  1. William Ping-Yiu Tong
    119 Tong
  2. Dean Bajorin
    402 Bajorin
  3. Glenn Heller
    291 Heller
  4. Susan Slovin
    184 Slovin
  5. William K Kelly
    108 Kelly
  6. Lawrence H Schwartz
    281 Schwartz
  7. Steven M Larson
    762 Larson
  8. Howard Scher
    816 Scher
  9. Kevin P Regan
    9 Regan