Summary
Docetaxel has been reported to show promising anti-tumour activity in pancreatic ductal cancer (PC). This study was conducted to evaluate the activity and toxicity of moderate-dose (60 mg m−2) docetaxel in Japanese chemo-naive patients with measurable metastatic PC. The patients had a performance status of 0–2. They received docetaxel intravenously over a 1- to 2-h period without any premedication for hypersensitivity reactions. This treatment was repeated every 3–4 weeks with dose adjustments based on the toxic effects observed. Twenty-one patients were eligible and treated with docetaxel. The median number of courses was 2 (range, 1–4). None of the patients achieved an objective response; seven showed no change and 13 showed progressive disease. In one patient, the response was not assessable because of early death. The median survival time for all patients was 118 days. The main grade 3–4 toxicities by patient were leucocytopenia (67%) and neutropenia (86%). Other grade 3–4 toxicities included anaemia (10%), thrombocytopenia (5%), nausea/vomiting (29%), anorexia (29%), GOT/GPT increase (10%), alkaline phosphatase increase (14%), malaise/fatigue (33%) and alopecia (24%). In conclusion, docetaxel, administered on this schedule, did not show significant anti-tumour activity in patients with metastatic PC.
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References
Abbruzzese, J. L., Evans, D., Gravel, D., Markowitz, A., Patt, Y. & Pazdur, R. (1995). Docetaxel (D), a potentially active agent for patients with pancreatic adenocarcinomas (PA). Proc Am Soc Clin Oncol 14: 221
Adachi, I., Watanabe, T., Takashima, S., Narabayashi, M., Horikoshi, N., Aoyama, H. & Taguchi, T. (1996). A late phase II study of RP56976 (docetaxel) in patients with advanced or recurrent breast cancer. Br J Cancer 73: 210–216.
Bissery, M. C., Guénard, D., Guéritte-Voegelein, F. & Lavelle, F. (1991). Experimental antitumor activity of Taxotere (RP56976, NSC628503), a Taxol analogue. Cancer Res 51: 4845–4852.
Bissett, D. & Kaye, S. B. (1993). Taxol and Taxotere: current status and future prospects. Eur J Cancer 29A: 1228–1231.
Bruno, R., Hille, D., Thomas, L., Riva, A. & Sheiner, L. B. (1995). Population pharmacokinetics/pharmacodynamics (PK/PD) of docetaxel (Taxotere) in phase II studies. Proc Am Soc Clin Oncol 14: 457
Cerny, T., Kaplan, S., Pavlidis, N., Schöffski, P., Epelbaum, R., van Meerbeek, J., Wanders, J. & Franklin, H. R., Kaye S., for the ECTG (Early Clinical Trials Group of the EORTC) (1994). Docetaxel (TaxotereTM) is active in non-small-cell lung cancer: a phase II trial of the EORTC early clinical trials group (ECTG). Br J Cancer 70: 384–387.
Cortes, J. E. & Pazdur, R. (1995). Docetaxel. J Clin Oncol 13: 2643–2655.
Dieras, V., Chevallier, B., Kerbrat, P., Krakowski, I., Roche, H., Misset, J. L., Lentz, M. A., Azli, N., Murawsky, M., Riva, A., Pouillart, P. & Fumoleau, P. (1996). A muticentre phase II study of docetaxel 75 mg m−2 as first-line chemotherapy for patients with advanced breast cancer: Report of the clinical screening group of the EORTC. Br J Cancer 74: 650–656.
Eisenhauer, E. A. (1995). Docetaxel: current status and future prospects. J Clin Oncol 13: 2865–2868.
Fleming, T. R. (1982). One-sample multiple testing procedure for phase II clinical trials. Biometrics 38: 143–151.
Francis, P., Schneider, J., Hann, L., Balmaceda, C., Barakat, R., Phillips, M. & Hakes, T. (1994). Phase II trial of docetaxel in patients with platinum-refractory advanced ovarian cancer. J Clin Oncol 12: 2301–2308.
Fumoleau, P., Chevallier, B., Kerbrat, P., Dieras, V., Le Bail, N., Bayssas, M. & Van Glabbeke, M. (1993). First line chemotherapy with TaxotereTM (T) in advanced breast cancer (ABC): a phase II study of the EORTC clinical screening group (CSG). Proc Am Soc Clin Oncol 12: 56
Guéritte-Voegelein, F., Guénard, D., Lavelle, F., Le Goff, M. T., Mangatal, L. & Potier, P. (1991). Relationships between the structure of Taxol analogues and their antimitotic activity. J Med Chem 34: 992–998.
Japan Society for Cancer Therapy (1993). Criteria for the evaluation of the clinical effects of solid cancer chemotherapy. J Jpn Soc Cancer Ther 28: 101–130.
Kunitoh, H., Watanabe, K., Onoshi, T., Furuse, K., Niitani, H. & Taguchi, T. (1996). Phase II trial of docetaxel in previously untreated advanced non-small-cell lung cancer: A Japanese Cooperative Study. J Clin Oncol 14: 1649–1655.
Miller, A. B., Hoogstraten, B., Staquet, M. & Winkler, A. (1981). Reporting results of cancer treatment. Cancer 47: 207–214.
Ministry of Health and Welfare (1991). The Japanese guidelines for the clinical evaluation of anti-neoplastic drugs. Mikusu, Tokyo
Rougie, P., De Forni, M., Adenis, A., Ducreux, M., Djazouli, K., Adams, D., Bonneterre, J., Clouet, P., Blanc, C., Bayssas, M. & Armand, J. P. (1994). Phase II study of Taxotere (RP56976, docetaxel) in pancreatic adenocarcinoma (PAC). Proc Am Soc Clin Oncol 13: 200
Rowinsky, E. K. & Donehower, R. C. (1995). Paclitaxel (Taxol). N Engl J Med 332: 1004–1014.
Schiff, P. B., Fant, J. & Horwitz, S. B. (1979). Promotion of microtubule assembly in vitro by Taxol. Nature 277: 665–667.
Simon, R. (1989). Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 10: 1–10.
Taguchi, T., Furue, H., Niitani, H., Ishitani, K., Kanamaru, R., Hasegawa, K., Ariyoshi, Y., Noda, K., Furuse, K., Fukuoka, M., Yakushiji, M. & Kashimura, M. (1994). Phase I clinical trial of RP56976 (docetaxel) a new anticancer drug (in Japanese, abstract in English). Jpn J Cancer Chemother 21: 1997–2005.
Tanigawara, Y., Sasaki, Y., Otsu, T., Fujii, H., Kashimura, M., Sasaki, T., Okumura, K. & Taguchi, T. (1996). Population pharmacokinetics of docetaxel in Japanese patients. Proc Am Soc Clin Oncol 15: 479
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Okada, S., Sakata, Y., Matsuno, S. et al. Phase II study of docetaxel in patients with metastatic pancreatic cancer: a Japanese cooperative study. Br J Cancer 80, 438–443 (1999). https://doi.org/10.1038/sj.bjc.6690375
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DOI: https://doi.org/10.1038/sj.bjc.6690375
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