European Journal of Cancer
Volume 39, Issue 13 , Pages 1866-1871 , September 2003

Phase II trial of pegylated-liposomal doxorubicin in the treatment of locally advanced unresectable or metastatic transitional cell carcinoma of the urothelial tract

  • E. Winquist

      Affiliations

    • Division of Medical Oncology, 790 Commissioners Road East, London, Ontario, Canada N6A 4L6
    • Corresponding Author InformationCorresponding author. Tel.: +1-519-685-8600; fax: +1-519-685-8624
    • ,
  • D.S. Ernst

      Affiliations

    • Department of Medical Oncology, Tom Baker Cancer Centre, Calgary, Alberta, Canada
    • ,
  • D. Jonker

      Affiliations

    • Division of Medical Oncology, 790 Commissioners Road East, London, Ontario, Canada N6A 4L6
    • ,
  • M.J. Moore

      Affiliations

    • Department of Medical Oncology, Princess Margaret Hospital, Toronto, Canada
    • ,
  • R. Segal

      Affiliations

    • Department of Medical Oncology, Ottawa Regional Cancer Centre, Ottawa, Canada
    • ,
  • G. Lockwood

      Affiliations

    • Department of Biostatistics, Princess Margaret Hospital, Toronto, Canada
    • ,
  • A. Rodgers

      Affiliations

    • Schering Canada Inc, Pointe-Claire, Quebec, Canada

Received 12 December 2002 ,Revised 31 January 2003 ,Accepted 4 April 2003.

References 

  1. Cancer Care Ontario Clinical Practice Guideline Initiative Genitourinary Disease Site Group. Use of chemotherapy in advanced unresectable or metastatic transitional cell carcinoma of the bladder or urothelium (Practice Guideline no. 3-12). http://www.hiru.mcmaster.ca/ccopgi/gencpg.html.
  2. von der Maase H, Hansen SW, Roberts JT, et al.  Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer (results of a large, randomized, multinational, multicenter, phase III study). J. Clin. Oncol. 2000;17:3068–3077
  3. Sternberg CN, de Mulder PH, Schornagel JH, et al.  Randomized phase III trial of high-dose-intensity methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) chemotherapy and human recombinant granulocyte colony-stimulating factor versus classic MVAC in advanced urothelial tract tumors (European Organization for Research and Treatment of Cancer protocol no. 30924). J. Clin. Oncol. 2001;19:2638–2646
  4. Saxman SB, Propert KJ, Einhorn LH, et al.  Long-term follow-up of a phase III intergroup study of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma (a cooperative group study). J. Clin. Oncol. 1997;15:2564–2569
  5. Yagoda A. Chemotherapy of urothelial tract tumors. Cancer. 1987;60:574–585
  6. Bajorin DF. Plenary debate of randomized phase III trial of neoadjuvant MVAC plus cystectomy versus cystectomy alone in patients with locally advanced bladder cancer. J. Clin. Oncol. 2001;19:17s–20s
  7. Gabizon AA. Pegylated liposomal doxorubicin (metamorphosis of an old drug into a new form of chemotherapy). Cancer Invest. 2001;19:424–436
  8. Muggia FM, Hainsworth JD, Jeffers S, et al.  Phase II study of liposomal doxorubicin in refractory ovarian cancer (antitumor activity and toxicity modification by liposomal encapsulation). J. Clin. Oncol. 1997;15:3185–3191
  9. Judson I, Radford JA, Harris M, et al.  Randomised phase II trial of pegylated liposomal doxorubicin (DOXIL®/Caelyx®) versus doxorubicin in the treatment of advanced or metastatic soft tissue sarcoma (a study by the EORTC Soft Tissue and Bone Sarcoma Group). Eur. J. Cancer. 2001;37:870–877
  10. Stewart S, Jablonowski H, Goebel FD, et al.  Randomized comparative trial of pegylated liposomal doxorubicin versus bleomycin and vincristine in the treatment of AIDS-related Kaposi's sarcoma. International Pegylated Liposomal Doxorubicin Study Group. J. Clin. Oncol. 1998;16:683–691
  11. Northfelt DW, Dezube BJ, Thommes JA, et al.  Pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine in the treatment of AIDS-related Kaposi's sarcoma (results of a randomized phase III clinical trial). J. Clin. Oncol. 1998;16:2445–2451
  12. Osoba D, Northfelt DW, Budd DW, Himmelberger D. Effect of treatment on health-related quality of life in acquired immunodeficiency syndrome (AIDS)-related Kaposi's sarcoma (a randomized trial of pegylated-liposomal doxorubicin versus doxorubicin, bleomycin, and vincristine). Cancer Invest. 2001;19:573–580
  13. Gordon AN, Fleagle JT, Guthrie D, Parkin DE, Gore ME, Lacave AJ. Recurrent epithelial ovarian carcinoma (a randomized phase III study of pegylated liposomal doxorubicin versus topotecan). J. Clin. Oncol. 2001;19:3312–3322
  14. Fossa SD, Aass N, Paro G. A phase II study of DaunoXome in advanced urothelial transitional cell carcinoma. Eur. J. Cancer. 1998;34:1131–1132
  15. Gordon AN, Granai CO, Rose PG, et al.  Phase II study of liposomal doxorubicin in platinum- and paclitaxel-resistant ovarian cancer. J. Clin. Oncol. 2000;18:3093–3100
  16. Gehan EA. The determination of the number of patients required in a preliminary and in a follow-up trial of a new chemotherapeutic agent. J. Chron. Dis. 1961;13:346–353
  17. Fossa SD, Splinter T, Roozendaal KJ, et al.  A phase II study of 4-epi-Adriamycin in advanced urothelial transitional cell cancer. Eur. J. Cancer Clin. Oncol. 1989;25:389–390
  18. Jones WG, Sokal MP, Ostrowski MJ, Newling DW. A phase II study of epirubicin in advanced transitional cell bladder cancer. The Yorkshire Urological Cancer Research Group. Clin. Oncol. (R. Coll. Radiol.). 1993;5:25–29
  19. Mazumdar M, Fazzari M, Panageas KS. Stat. Med. 2001;20:883–892
  20. Roth BJ, Dreicer R, Einhorn LH, et al.  Significant activity of paclitaxel in advanced transitional-cell carcinoma of the urothelium (a phase II trial of the Eastern Cooperative Oncology Group). J. Clin. Oncol. 1994;12:2264–2270
  21. Yang MH, Yen CC, Chang YH, et al.  Single agent paclitaxel as a first-line therapy in advanced urothelial carcinoma (its efficacy and safety in patients even with pretreatment renal insufficiency). Jpn. J. Clin. Oncol. 2000;30:547–552
  22. Stadler WM, Kuzel T, Roth B, et al.  Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J. Clin. Oncol. 1997;15:3394–3398
  23. Moore MJ, Tannock IF, Ernst DS, et al.  Gemcitabine (a promising new agent in the treatment of advanced urothelial cancer). J. Clin. Oncol. 1997;15:3441–3445
  24. De Wit R, Kruit WHJ, Stoter G, et al.  Docetaxel (Taxotere) (an active agent in metastatic urothelial cancer; results of a phase II study in nonchemotherapy-pretreated patients). Br. J. Cancer. 1998;78:1342–1345
  25. Schwonzen M, Kurbacher CM, Mallmann P. Liposomal doxorubicin and weekly paclitaxel in the treatment of metastatic breast cancer. Anticancer Drugs. 2000;11:681–685
  26. Rivera E, Valero V, Syrewicz L, et al.  Phase I study of stealth liposomal doxorubicin in combination with gemcitabine in the treatment of patients with metastatic breast cancer. J. Clin. Oncol. 2001;19:1716–1722
  27. Sparano JA, Malik U, Rajdev L, et al.  Phase I trial of pegylated liposomal doxorubicin and docetaxel in advanced breast cancer. J. Clin. Oncol. 2001;19:3117–3125
  28. Eng C, Mauer AM, Fleming GF, et al.  Phase I study of pegylated lipsomal doxorubicin, paclitaxel, and cisplatin in patients with advanced solid tumors. Ann. Oncol. 2001;12:1743–1747
  29. Koukourakis MI, Koukouraki S, Giatromanolaki A, et al.  Liposomal doxorubicin and conventionally fractionated radiotherapy in the treatment of locally advanced non-small-cell lung cancer and head and neck cancer. J. Clin. Oncol. 1999;17:3512–3521

PII: S0959-8049(03)00358-7

doi: 10.1016/S0959-8049(03)00358-7

European Journal of Cancer
Volume 39, Issue 13 , Pages 1866-1871 , September 2003

Article Tools