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Phase I trial of weekly docetaxel with a 4-weekly cisplatin administration in patients with advanced gastric carcinoma

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Abstract

The docetaxel-cisplatin combination is active against several tumors including gastric cancer but it is followed by severe myelosuppression. Recent experience with weekly taxanes has demonstrated a mild myelotoxicity with high dose intensity. We investigated in a phase I study a weekly schedule of docetaxel on days 1, 8 and 15 and cisplatin on day 1 every 4 weeks in 19 patients with advanced gastric cancer with no prior chemotherapy. Cohorts of patients were treated with escalating doses of docetaxel (starting dose 30 mg/m2 per week and increments of 10 mg/m2 per week) and cisplatin (starting dose 70 mg/m2 and increments of 5 mg/m2). Febrile neutropenia was the only dose-limiting event occurring in four (20%) patients; the dose-limiting toxicity was reached at dose level three (docetaxel 40 mg/m2 per week and cisplatin 75 mg/m2). The maximum-tolerated dose was 40 mg/m2 per week for docetaxel and 70 mg/m2 every 4 weeks for cisplatin. Grade 3/4 neutropenia occurred in six patients (30%); early death occurred in one patient with septic shock because of neutropenia and another with acute coronary ischemia. Two (11%) complete and two (11%) partial responses were documented (ORR 22%; 95% CI 3–39%), with a median response duration of 5 months and median time to progression of 7 months. In conclusion, the combination of weekly docetaxel plus cisplatin is feasible with moderate toxicity and merits further investigation in phase II studies in advanced gastric cancer.

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References

  1. Ajani JA (1998) Current status of therapy for advanced gastric cancer. Oncology 12 [Suppl 6]:99–102

    CAS  Google Scholar 

  2. Preusser P, Achterrath W, Wilke H, et al (1988) Chemotherapy of gastric cancer. Cancer Treat Rev 15:257–277

    Article  CAS  PubMed  Google Scholar 

  3. Webb A, Cunningham D, Scarffe JH, et al (1997) Randomized trial comparing epirubicin cisplatin and fluorouracil versus fluorouracil, doxorubicin and methotrexate in advanced esophagogastric cancer. J Clin Oncol 15(1):261–267

    CAS  PubMed  Google Scholar 

  4. Cascinu S, Ficarelli R, Safi MAA, et al (1997) A phase I study of paclitaxel and 5-fluorouracil in advanced gastric cancer. Eur J Cancer 33:1699–1702

    Article  CAS  PubMed  Google Scholar 

  5. Murad AM, Petroianu A, Guimaraes RC, et al (1999) Phase II trial of the combination of paclitaxel and 5-fluorouracil in the treatment of advanced gastric cancer: a novel, safe, and effective regimen. Am J Clin Oncol 22:580–586

    Article  CAS  PubMed  Google Scholar 

  6. Kim YH, Shin SW, Kim BS, et al (1999) Paclitaxel, 5-fluorouracil, and cisplatin combination chemotherapy in the treatment of advanced gastric carcinoma. Cancer 85:295–301

    Article  CAS  PubMed  Google Scholar 

  7. Kollmannsberger C, Quietzsch D, Haang C, et al (2000) A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, FA and cisplatin in patients with advanced gastric cancer. Br J Cancer 83:458–462

    Article  CAS  PubMed  Google Scholar 

  8. Stathopoulos GR, Rigatos SK, Fountzilas G, et al (2002) Paclitaxel and carboplatin in pretreated advanced gastric cancer: a phase II study. Oncol Rep 9:89–92

    CAS  PubMed  Google Scholar 

  9. Mavroudis D, Kakolyris S, Kouroussis, et al (1999) First line treatment of advanced gastric cancer with docetaxel monotherapy and granulocyte colony-stimulating factor (G-CSF) (abstract 977). Proc Am Soc Clin Oncol 18:254a

    Google Scholar 

  10. Vanhoefer U, Wilke H, Harstrick A, et al (1999) Phase II study of docetaxel as second line chemotherapy (CT) in metastatic gastric cancer (abstract 1163). Proc Am Soc Clin Oncol 18:303a

    Google Scholar 

  11. Graziano F, Catalano V, Baldelli AM, et al (2000) A phase II study of weekly docetaxel as salvage chemotherapy for advanced gastric cancer. Ann Oncol 11:1263–1266

    Article  CAS  PubMed  Google Scholar 

  12. Ajani JA, Fodor M, van Cutsem E, et al (2000) Multinational randomized phase II trial of docetaxel (T) and cisplatin (C) with or without 5-fluorouracil (FU) in patients (pts) with advanced gastric or GE junction adenocarcinoma (AGC-AGEJC) (abstract 957). Proc Am Soc Clin Oncol 19:247a

    Google Scholar 

  13. Roth AD, Maibach R, Martinelli G, et al (2000) Docetaxel (Taxotere)-cisplatin (TC): an effective drug combination in gastric carcinoma. Swiss Group for Clinical Cancer Research (SAKK), and the European Institute of Oncology (EIO). Ann Oncol 11:301–306

    Article  CAS  PubMed  Google Scholar 

  14. Ridwelski K, Gebauer T, Fahlke J, et al (2001) Combination chemotherapy with docetaxel and cisplatin for locally advanced and metastatic gastric cancer. Ann Oncol 12:47–51

    Article  CAS  PubMed  Google Scholar 

  15. Constenla M, Lorenzo I, Carrete N, et al (1999) Docetaxel with weekly high-dose-5-FU and leucovorin: a new combination in advanced gastric cancer (abstract 1079). Proc Am Soc Clin Oncol 18:281a

    Google Scholar 

  16. André T, Louvet C, Ychou M, et al (1999) Docetaxel-epirubicin as second-line treatment for patients with advanced gastric cancer (abstract 1062). Proc Am Soc Clin Oncol 18:277a

    Google Scholar 

  17. Murad AM, Vinholes J, Skare N, et al (2002) A phase II multicentric trial of docetaxel (Taxotere), 5-fluorouracil (5-FU) and epirubicin (EPI) in previously untreated advanced gastric cancer: a novel and effective regimen (abstract 650). Proc Am Soc Clin Oncol 21:163a

    Google Scholar 

  18. Fennely D, Aghajanian C, Shapiro F, et al (1997) Phase I and pharmacologic study of paclitaxel administered weekly in patients with relapsed ovarian cancer. J Clin Oncol 15:187–192

    PubMed  Google Scholar 

  19. Hainswoth JD, Burris HA III, Erland JB, et al (1998) Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer. J Clin Oncol 16(6):2164–2168

    PubMed  Google Scholar 

  20. Miller AB, Hoogstraten B, Staquet M, Winkler A (1981) Reporting results of cancer treatment. Cancer 47:207–214

    CAS  PubMed  Google Scholar 

  21. Seidman AD, Murphy B, Hudis C, et al (1997) Activity of Taxol by weekly 1-hour infusion in patients with metastatic breast cancer: a phase II and pharmacologic study (abstract). Proc Am Soc Clin Oncol 16:148A

    Google Scholar 

  22. Koizumi T, Tsunoda T, Fujimoto K, et al (2001) Phase I trial of weekly docetaxel combined with cisplatin in patients with non-small cell lung cancer. Lung Cancer 34(1):125–131

    Article  CAS  PubMed  Google Scholar 

  23. Schütte W, Nagel S, Lantenschläger C, et al (2002) Randomized phase II study of weekly versus three-weekly docetaxel as second line chemotherapy for advanced non-small cell lung cancer (abstract 1228). Proc Am Soc Clin Oncol 21:308a

    Google Scholar 

  24. Camps C, Massuti B, Jinenez AM, et al (2003) Second-line docetaxel administrated every 3 weeks versus weekly in advanced non-small cell lung cancer: a Spanish Lung Cancer Group (SLCG) phase III trial (abstract 2514). Proc Am Soc Clin Oncol 22:625

    Google Scholar 

  25. Gridelli C, Illiano A, Salvagui S, et al (2003) Effect on quality-of-life of weekly vs 3-weekly docetaxel in second-line treatment of advanced non-small-cell-lung cancer. The DISTAL randomized phase 3 study (abstract 2515). Am Soc Clin Oncol 22:625a

    Google Scholar 

  26. Ohe Y, Niho S, Kakinuma R, et al (2004) A phase II study of cisplatin and docetaxel administered as three consecutive weekly infusions for advanced non-small-cell lung cancer in elderly patients. Ann Oncol 15:45–50

    Article  CAS  PubMed  Google Scholar 

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Authors and Affiliations

  1. Medical Oncology Unit, Laikon General Hospital, Athens University School of Medicine, Athens, Greece

    Aristides Polyzos

  2. Medical Oncology Unit of Third Department of Medicine, Sotiria General Hospital, Athens University School of Medicine, Athens, Greece

    Konstantinos Syrigos

  3. First Department of Medical Oncology, Theagenion Anticancer Hospital, Thessaloniki, Greece

    John Stergiou

  4. Second Department of Medical Oncology, Agios Savas Cancer Hospital, Athens, Greece

    Christos Panopoulos

  5. First Department of Medical Oncology, Metaxa’s Anticancer Hospital, Pireas, Greece

    Anna Potamianou

  6. Department of Medical Oncology, University General Hospital of Heraklion, Crete, Greece

    Lambros Vamvakas & Vassilios Georgoulias

Authors
  1. Aristides Polyzos
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  2. Konstantinos Syrigos
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  3. John Stergiou
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  4. Christos Panopoulos
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  5. Anna Potamianou
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  6. Lambros Vamvakas
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  7. Vassilios Georgoulias
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Correspondence to Aristides Polyzos.

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Polyzos, A., Syrigos, K., Stergiou, J. et al. Phase I trial of weekly docetaxel with a 4-weekly cisplatin administration in patients with advanced gastric carcinoma. Cancer Chemother Pharmacol 55, 466–470 (2005). https://doi.org/10.1007/s00280-004-0912-0

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  • DOI: https://doi.org/10.1007/s00280-004-0912-0

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