Abstract
Based on results of a phase I study demonstrating antitumor activity of taxol in patients with melanoma, 34 patients with documented metastatic melanoma received taxol, 250 mg/m2, as a 24-hours infusion, repeated every 21 days, in this phase II study. All patients received premedication with dexamethasone, diphenhydramine and cimetidine. Four patients experienced anaphylactic reactions and stopped treatment. Other significant toxicity of this drug included short-lived but severe neutropenia (< 1,0007mm2) and peripheral neurotoxicity. Four of 28 evaluable patients demonstrated objective response (14%) (confidence interval, 4%–33%) including 3 complete responses and 1 partial response. Two complete responders are continuing at 25 + and 38 + months after achieving CR. Minor evidence of anti-tumor activity was noted in five additional patients. Taxol has significant activity in melanoma and should be further studied in combination with other agents in this disease.
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Wani MC, Taylor HL, Wall ME, et al.: Plant antitumor agents VI. The isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia. J Am Chem Soc 93:2325–2329, 1971
Schiff PB, Fant J, Horwitz SB: Promotion of microtubule assembly in vitro by taxol. Nature (London) 277:665–667, 1979
Schiff PB, Horwitz SB: Taxol stabilizes microtubules in mouse fibroblast cells. Proc Natl Acad Sci, (USA) 77:1561–1565, 1980
Kris MG, O'Connell JP, Gralla RJ, et al.: Phase I trial of taxol given as a 3-hour infusion every 21 days. Cancer Treat Rep 70:605–607, 1986
Longnecker SM, Donehower RC, Gates AE, et al.: High-performance liquid chromotographic assay for Taxol in human plasma and urine and pharmacokinetics in a phase I trial. Cancer Treat Rep 71:53–59, 1987
Donehower RC, Rowinsky EK, Grochow LB, et al.: Phase I trial of Taxol in patients with advanced cancer. Cancer Treat Rep 71:1171–1177, 1987
Grem JL, Tutsch KD, Simon KJ, et al.: Phase I study of Taxol administered as a short IV infusion daily for 5 days. Cancer Treat Rep 71:1179–1184, 1987
Wiernik PH, Schwartz EL, Strauman JJ, et al.: Phase I clinical and pharmacokinetic study of Taxol. Cancer Res 47:2486–2493, 1987
Ohnuma T, Zimet AS, Coffey VA, et al.: Phase I study of taxol in a 24-hr infusion schedule. Proc Am Assoc Cancer Res 26:167, 1985 (abstr)
Legha S, Tenney DM and Krakoff IR: A Phase I study of Taxol using a 5-day intermittent schedule, J Clin Oncol 4:762–766, 1986
Wiernik PH, Schwartz EL, Einzig A, et al.: Phase I Trial of Taxol given as a 24-hour infusion every 21 days: Responses observed in metastatic melanoma. J Clin Oncol 5:1232–1239, 1987
Einzig AI, Trump DL, Sasloff J, et al.: Phase II pilot study of taxol in patients with malignant melanoma. Proc Am Soc Clin Oncol 7:249, 1988
Oken MM, Creech RN, Tormey DC, et al.: Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649–655, 1982
Legha SS, Ring S, Papadopoulos N, et al.: Taxol: A Phase II study in patients with metastatic melanoma. Cancer 65:2478–2481, 1990
Lipton RB, Apfel SC, Dutcher JP, et al.: Taxol produces a predominantly sensory neuropathy. Neurol 39:368–373, 1989
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Einzig, A.I., Hochster, H., Wiernik, P.H. et al. A phase II study of taxol in patients with malignant melanoma. Invest New Drugs 9, 59–64 (1991). https://doi.org/10.1007/BF00194546
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DOI: https://doi.org/10.1007/BF00194546