Phase II study of paclitaxel therapy for unresectable biliary tree carcinomas

D. V. Jones, R. Lozano, A. Hoque, Avi Markowitz, Y. Z. Patt

    Research output: Contribution to journalArticle

    99 Citations (Scopus)

    Abstract

    Purpose: To evaluate the efficacy of paclitaxel administered to patients with unresectable adenocarcinomas of the gallbladder and biliary tree over 3 hours every 21 days. Patients and Methods: Fifteen patients with unresectable and/or metastatic carcinoma of the gallbladder and bile ducts received intravenous paclitaxel over 3 hours after premedication with dexamethasone, diphenhydramine, and cimetidine. Treatment was repeated every 21 days, and one complete course of therapy was comprised of two such 21- day treatment cycles. The initial dose of paclitaxel was 170 mg/m2, and this was elevated to 200 mg/m2 due to tolerance within the initial patient cohort. Results: All patients were assessable for both toxicity and response: 11 with bile duct cancer and four with gallbladder carcinoma. Forty-three cycles of therapy were delivered during the trial (median, two), and one patient remains on treatment. No complete or partial responses were noted, although two patients achieved minor responses that lasted 2 and 2+ months, respectively. There were no deaths on this study, and all but one of the patients is still alive. The therapy was well tolerated, and hematologic and mucosal toxic effects were moderate and readily reversible, although significant neuromuscular adverse effects were noted. Conclusion: These findings indicate that paclitaxel administered on this schedule, is tolerable, but is unlikely to have activity in metastatic carcinomas of the biliary tree. It is unclear whether a different regimen of paclitaxel, or another taxane, may have activity in these neoplasms.

    Original languageEnglish (US)
    Pages (from-to)2306-2310
    Number of pages5
    JournalJournal of Clinical Oncology
    Volume14
    Issue number8
    StatePublished - 1996

    Fingerprint

    Biliary Tract
    Paclitaxel
    Carcinoma
    Gallbladder
    Therapeutics
    Neuromuscular Agents
    Bile Duct Neoplasms
    Diphenhydramine
    Premedication
    Poisons
    Cimetidine
    Bile Ducts
    Dexamethasone
    Appointments and Schedules
    Adenocarcinoma

    ASJC Scopus subject areas

    • Cancer Research
    • Oncology

    Cite this

    Jones, D. V., Lozano, R., Hoque, A., Markowitz, A., & Patt, Y. Z. (1996). Phase II study of paclitaxel therapy for unresectable biliary tree carcinomas. Journal of Clinical Oncology, 14(8), 2306-2310.

    Phase II study of paclitaxel therapy for unresectable biliary tree carcinomas. / Jones, D. V.; Lozano, R.; Hoque, A.; Markowitz, Avi; Patt, Y. Z.

    In: Journal of Clinical Oncology, Vol. 14, No. 8, 1996, p. 2306-2310.

    Research output: Contribution to journalArticle

    Jones, DV, Lozano, R, Hoque, A, Markowitz, A & Patt, YZ 1996, 'Phase II study of paclitaxel therapy for unresectable biliary tree carcinomas', Journal of Clinical Oncology, vol. 14, no. 8, pp. 2306-2310.
    Jones DV, Lozano R, Hoque A, Markowitz A, Patt YZ. Phase II study of paclitaxel therapy for unresectable biliary tree carcinomas. Journal of Clinical Oncology. 1996;14(8):2306-2310.
    Jones, D. V. ; Lozano, R. ; Hoque, A. ; Markowitz, Avi ; Patt, Y. Z. / Phase II study of paclitaxel therapy for unresectable biliary tree carcinomas. In: Journal of Clinical Oncology. 1996 ; Vol. 14, No. 8. pp. 2306-2310.
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