Abstract
The aim of this study was to evaluate the clinical efficacy and safety of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy. Docetaxe1100 mg m−2 was administered as a 1 hour intravenous (IV) infusion every 3 weeks to 41 patients. Patients were premedicated prior to each course with dexamethasone, diphenhydramine and cimetidine. Clinical response and toxicity were determined. Objective responses were seen in seven of 41 eligible patients (two complete responses [CRs] and five partial responses [PRs], for an objective response rate of 17% (90% confidence interval [CI], 8% to 30%). The most common toxicity was grade 4 neutropenia, which occurred in 88% of patients; 46% of patients required a dose reduction following an episode of neutropenic fever requiring antibiotic therapy. Additional patients have had reversible grade 3–4 toxicities including nausea, vomiting, stomatitis, diarrhea, fatigue and peripheral neuropathy. Ten patients have had grade 1–3 hypersensitivity reactions. Alopecia has been seen in the majority of patients. Fluid retention grade 1–3 has been observed in patients. Docetaxel administered on this schedule is an active agent in adenocarcinomas of the upper gastrointestinal tract. Further investigation of this drug should be conducted in multi-drug combination programs.
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Diaz, J.F. and Andreu, J.M. (1993) Assembly of purified GDP-tubulin into microtubules induced by Taxol and Taxotere: Reversibility, ligand stoichiometry, and competition.Biochemistry 32, 2747–55.
Ringel, I. and Horwitz, S.B. (1991) Studies with RP 56976 (Taxotere): A semisynthetic analogue of Taxol.J. Natl. Cancer Inst. 83, 288–91.
Gueritte-Voegelein, F., Guenard, D., Lavelle, F.et al. (1991) Relationships between the structure of taxol analogues and their antimitotic activity.J. Med. Chem. 34, 992–8.
Kelland, L.R. and Abel, G. (1992) Comparativein vitro cytotoxicity of Taxol and Taxotere against cisplatin-sensitive and -resistant human ovarian carcinoma cell lines.Cancer Chemother. Pharmacol. 30, 444–50.
Braakhuis, B.J., Hill, B.T., Dietel, M.et al. (1994)In vitro antiproliferative activity of docetaxel (Taxotere), paclitaxel (Taxol) and cisplatin against human tumor and normal bone marrow cells.Anticancer Res. 14, 205–8.
Bissery, M.C., Guenard, D., Guerite-Voegelein, F.et al. (1991) Experimental antitumor activity of Taxotere (RP 56976, NCS 628503), a Taxol analogue.Cancer Res. 51, 4845–52.
Extra, J.M., Rousseau, F., Bruno, R.et al. (1993) Phase I and pharmacokinetic study of Taxotere (RP45976; NSC 628503) given as a short intravenous infusion.Cancer Res. 53, 1037–42.
Bisset, D., Setanoians, A., Cassidy, J.et al. (1993) Phase I and pharmacokinetic study of Taxotere (RP 56976) administered as a 24-hour infusion.Cancer Res. 53, 523–7.
Pazdur, R., Newmann, R.A., Newmann, B.M.et al. (1992) Phase I trial of Taxotere, hve day schedule.J. Natl. Cancer Inst. 84, 1781–8.
Burris, H.A., Irvin, R., Kuhn, J.et al. (1993) Phase I Trial of Taxotere administered as either a 2-hour or 6-hour infusion.J. Clin. Oncol. 11, 950–8.
Tomiak, E., Piccart, M.J., Kerger, J.et al. (1994) Phase I study of docetaxel administered as an intravenous 1-hour infusion on a weekly basis.J. Clin. Oncol. 12, 1458–67.
Francis, P.A., Rigas, J.R., Kris, M.G.et al. (1994) Phase II trial of docetaxel in patients with stage [II and IV non small cell lung cancer.J. Clin. Oncot. 12, 1232–7.
Fossella, F.V., Lee, J.S., Murphy, W.K.et al. (1994) Phase II study of docetaxel for recurrent or metastatic non-small cell lung cancer.J. Clin. Oncol. 12, 1238–44.
Fossella, F.V., Lee, J.S., Shinn, D.M.et al. (1995) Phase II study of docetaxel for advanced or metastatic platinumrefractory non-small cell lung cancer.J. Clin. Oncol. 13, 645–51.
Cerny, T., Kaplan, S., Pavlidis, N.et al. (1994) Docetaxel (Taxotere) is active in non-small cell lung cancer: A phase II study of the EORTC early clinical trials group (ECTG).Br. J. Cancer 70, 384–7.
Fossella, F.V., Lee, J.S., Berille, J.et al. (1995) Summary of the phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of non-small cell lung cancer.Semin. Oncol. 22, 22–9 (suppl. 4).
Ten Bokkel Huinink, W.W., Prove, A.M., Piccart, M.et al. (1994) A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer.Ann. Oncol. 5, 527–32.
Chevalier, B., Fumoleau, P., Kerbrat, P.et al. (1995) Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer: A phase II trial of the Clinical Screening Cooperative Group of the European Organization for the Research and treatment of Cancer.J. Clin. Oncol. 13, 314–22.
Dieras, V., Fumoleau, P., Chevalier, B.et al. (1994) Second EORTC Clinical Screening Group (CSG) phase II trial of taxotere (docetaxel) as first line chemotherapy in advanced breast cancer.Proc. Am. Soc. Clin. Oncol. 13, 78 (abstr).
Trudeau, M.E., Eisenhauer, E., Lofters, W.et al. (1993) Phase II study of Taxotere as first-line chemotherapy for metastatic breast cancer. A National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study.Proc. Am. Soc. Clin. Oncol. 12, 64 (abstr).
Seidman, A.D., Hudis, C., Crown, J.P.et al. (1993) Phase lI evaluation of Taxotere (RP56976, NSC628503) as initial chemotherapy for metastatic breast cancer.Proc. Am. Soc. Clin. Oncol. 12, 63 (abstr).
Ravdin, P.M. and Valero, V. (1995) Review of docetaxel (Taxotere), a highly active new agent for the treatment of metastatic breast cancer.Semin. Oncol. 22, 17–21 (suppl 4).
Francis, P., Schneider, J., Hann, L.et al. (1994) Phase II trial of docetaxel in patients with platinum refractory ovarian cancer.J. Clin. Oncol. 12, 2301–8.
Piccart, M.J., Gore, M., ten Bokkel Huinnink, W.et al. (1995) Docetaxel: An active new drug for treatment of advanced epithelial ovarian cancer.J. Natl. Cancer Inst. 87, 676–81.
Catimet, G., Vermeij, J., Mattijsen, V. et al. (1994) Docetaxel (Taxotere): An active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck.Ann. Oncol. 5, 533–7.
McCaffery, J., Hilton, S., Bajorin, D.et al. (1995) Docetaxel in patients with advanced transitional cell cancer (TCC) who failed cisplatin-based chemotherapy: A phase II trial.Proc. Am. Acc. Clin. Oncol. 14, 233 (abstr).
Sulkes, A., Smyth, J., Sessa, C.et al. (1994) Docetaxel (Taxotere) in advanced gastric cancer: Results of phase II clinical trial.Br. J. Cancer 70, 380–3.
Oken, M.M., Creech, R.H., Tormey, D.C.et al. (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group.Am. J. Clin. Oncol. 5, 649–55.
Atkinson, E.N. and Brown, B.W. (1985) Confidence limits for probability of response in multi-stage phase II clinical trials.Biometrics 41, 741–4.
Kaplan, E.L. and Meir, P. (1958) Nonparametric estimation from incomplete observation. J. Am. Stat. Assoc. 53, 457–81.
Corals, R.L. and Carter, S.K. (1994) A review of chemotherapy in gastric cancer.Cancer 34, 1576–86.
Alexander, H., Kelsen, D. and Tepper, J. (1993) Cancer of the stomach. In: V. De Vita Jr., S. Hellman and S. Rosenberg (eds) Cancer: principles and practice of oncology, 4th edn, pp. 818–48. Philadelphia: J.B. Lippincott.
Preusser, P., Achterrath, W., Wilke, H. et al. (1988) Chemotherapy of gastric cancer.Cancer Treat Rev. 15, 257–77.
Preusser, P., Wilke, H., Achterrath, W.et al. (1989) Phase II study with the combination of etoposide, doxorubicin, and cisplatin in advanced measurable gastric cancer.J. Clin. Oncol. 7, 1310–7.
Kelsen, D., Atiq, O.T., Saltz, L.et al. (1992) FAMTX versus etoposide, doxorubicin and cisplatin: a randomized assignment trial in gastric cancer.J. Clin. Oncol. 10, 541–8.
Lerner, A., Gonin, R., Steele, G.D. Jr. and Moyer, R.J. (1992) Etoposide, doxorubicin, and cisplatin chemotherapy for advanced gastric adenocarcinoma: results of a phase II trial.J. Clin. Oncol. 10, 536–40.
Wils, J.A., Klein, H.O., Wagener, D.J.et al. (1991) Sequential high-dose methotrexate and fluorouracil combined with doxorubicin — a step ahead in the treatment of advanced gastric cancer: a trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cooperative Group.J. Clin. Oncol. 9, 827–31.
Cullinan, S.A., Moertel, C.E., Wieand, H.S.et al. (1994) Controlled evaluation of three drug combination regimens versus fluorouracil alone for the therapy of advanced gastric cancer.J. Clin. Oncol. 12, 412–6.
Eisenhower, E. (1995) Editorial, Docetaxel: Current status and future prospects.J. Clin. Oncol. 13, 2865–8.
Einzig, A.I., Lipsitz, S., Wiernik, P.H.et al. (1996) Phase II Trial of Taxol in patients with adenocarcinoma of the upper gastrointestinal tract.Invest. New Drugs (in Press).
Ajari, J.A., llson, B.A., Daugherty, K.etal. (1994) Activity of taxol in patients with squamous cell carcinoma and adenocarcinoma of the esophagus.J. Natl. Cancer Inst. 86, 1086–91.
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Einzig, A.I., Neuberg, D., Remick, S.C. et al. Phase II trial of docetaxel (Taxotere) in patients with adenocarcinoma of the upper gastrointestinal tract previously untreated with cytotoxic chemotherapy: the Eastern Cooperative Oncology Group (ECOG) Results of Protocol E1293. Med Oncol 13, 87–93 (1996). https://doi.org/10.1007/BF02993858
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DOI: https://doi.org/10.1007/BF02993858