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Vol. 68, No. 2-3, 2005
Issue release date: July 2005

Phase II Study of Docetaxel and Capecitabine in Patients with Metastatic or Recurrent Gastric Cancer

Kim J.G. · Sohn S.K. · Kim D.H. · Baek J.H. · Sung W.J. · Park J.Y. · Kim T.B. · Jung H.Y. · Yu W. · Lee K.B.
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Abstract

Objectives: A phase II study was conducted to evaluate the response rate and safety of a combination regimen of docetaxel plus capecitabine in patients with advanced gastric cancer. Patients and Methods: Patients with previously untreated metastatic or recurrent measurable gastric cancer received i.v. docetaxel 75 mg/m2 on day 1 and oral capecitabine 1,000 mg/m2 twice daily from day 1 to 14 every 3-week cycle. Results: Thirty-two patients were enrolled in the current study. Of these, 30 patients were assessable for efficacy and 31 assessable for toxicity. One complete response and 13 partial responses were confirmed, giving an overall response rate of 43.8% (95% CI; 25.6–61.9%). The median time to progression and median overall survival for all patients was 5.07 months and 8.4 months, respectively. Grade 3/4 neutropenia occurred in 3 patients (9.7%) and febrile neutropenia was observed in 2 patients (6.3%). Grade 1/2 nausea was observed in 45.2% of patients. Grade 2–3 hand-foot syndrome occurred in 4 patients (12.9%). Conclusions: The combination of docetaxel and capectabine was found to be well tolerated and effective in patients with advanced gastric cancer. Accordingly, this regimen can be regarded as an important first-line treatment option for advanced gastric cancer.



Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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References

  1. Murad AM, Santiago FF, Petroianu A, et al: Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer. Cancer 1993;72:37–41.
  2. Pyrhonen S, Kuitunen T, Kouri M: A randomized, Phase III trial comparing fluorouracil, epidoxorubicin and methotrexate (FEMTX) with best supportive care in non-resectable gastric cancer (abstract). Ann Oncol 1992;3(suppl):12.
  3. Glimelius B, Hoffmann K, Haglund U, et al: Initial or delayed chemotherapy with best supportive care in advanced gastric cancer. Ann Oncol 1994;5:189–190.
  4. Kim NK, Park YS, Heo DS, et al: A phase III randomized study of 5-fluorouracil and cisplatin versus 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil alone in the treatment of advanced gastric cancer. Cancer 1993;71:3813–3818.
  5. Vanhoefer U, Wagner T, Lutz M, et al: Randomized phase II study of weekly 24-h infusion of high dose 5-FU ± folinic acid (HD-FU ± FA) versus HD-FU/FA/biweekly cisplatin in advanced gastric cancer. EORTC-trial 40953. Eur J Cancer 2001;37:27.

    External Resources

  6. Roth AD, Maibach R, Martinelli G, et al: Docetaxel (Taxotere)-cisplatin (TC): An effective drug combination in gastric carcinoma. Ann Oncol 2000;11:301–306.
  7. Boku N, Ohtsu A, Shimada Y, et al: Phase II study of a combination of irinotecan and cisplatin against metastatic gastric cancer. J Clin Oncol 1999;17:319–323.
  8. Pazdur R, Kudelka AP, Kavanagh JJ, et al: The taxoids: Paclitaxel (Taxol) and docetaxel (Taxotere). Cancer Treat Rev 1993;19:351–386.
  9. Sulkes A, Smyth J, Sessa C, et al: Docetaxel (Taxotere) in advanced gastric cancer: Results of a phase II clinical trial. EORTC Early Clinical Trials Group. Br J Cancer 1994;70:380–383.
  10. Bang YJ, Kang WK, Kang YK, et al: Docetaxel 75 mg/m2 is active and well tolerated in patients with metastatic or recurrent gastric cancer: A phase II trial. Jpn J Clin Oncol 2002;32:248–254.
  11. Ajani JA, Van Cutsem E, Moiseyenko V, et al: Docetaxel (D), cisplatin, 5-fluorouracil compare to cisplatin (C) and 5-fluorouracil (F) for chemotherapy naïve patients with metastatic or locally recurrent, unresectable gastric carcinoma (MGC): Interim results of a randomized phase III trial (V325). Proc Am Soc Clin Oncol 2003;22:249.
  12. Miwa M, Ura M, Nishida M, et al: Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generate 5-fluorouracil selectively in tumors by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 1998;34:1274–1281.
  13. Schuller J, Cassidy J, Dumont E, et al: Preferential activation of capecitabine in tumor following oral administration in colorectal cancer patients. Cancer Chemother Pharmacol 2000;34:293–296.
  14. Koizumi W, Saigenji K, Ujiie S, et al: A pilot phase II study of capecitabine in advanced or recurrent gastric cancer. Oncololgy 2003;64:232–236.
  15. Kim TW, Kang YK, Ahn JH, et al: Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer. Ann Oncol 2002;13:1893–1898.
  16. Blum JL, Jones SE, Buzdar AU, et al: Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1999;17:485–493.
  17. Van Cutsem E, Twelves C, Cassidy J, et al: Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: Results of a randomized phase III study. J Clin Oncol 2001;19:4097–4106.
  18. Hoff PM, Ansari R, Batist G, et al: Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study. J Clin Oncol 2001;19:2282–2292.
  19. Sawada N, Ishikawa T, Fukase Y, et al: Induction of thymidine phosphorylase activity and enhancement of capecitabine efficacy by taxol/taxotere in human cancer xenografts. Clin Cancer Res 1998;4:1013–1019.
  20. O’Shaughnessy J, Miles D, Vukelja S, et al: Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase II trial results. J Clin Oncol 2002;20:28.

    External Resources

  21. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205–216.
  22. Simon R: Optimal two-stage designs for phase II clinical trials. Controlled Clin Trials 1989;10:1–10.
  23. Park YH, Ryoo BY, Choi SJ, Kim HT: A phase II study of capecitabine and docetaxel combination chemotherapy in patients with advanced gastric cancer. Br J Cancer 2004;90:1329–1333.


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