Medical Oncology

, Volume 16, Issue 4, pp 261–266 | Cite as

Phase II protocol for the evaluation of new treatments in patients with advanced gastric carcinoma: results of ECOG 5282

  • Y Novik
  • LM Ryan
  • DG Haller
  • R Asbury
  • JP Dutcher
  • A Schutt
Original Paper


The study was a Phase II randomized study to evaluate the efficacy of new agents for the treatment of advanced gastric carcinoma. Patients were randomized to receive single agent chemotherapy with mitoxantrone, etoposide, aclacinomycin-A or spirogermanium. The patients were stratified by prior use of chemotherapy, prior doxorubicin use and ECOG performance status. Patients with a history of cardiac disease or prior doxorubicin exceeding a dose of 400 mg/m2 were restrictively randomized to sopirogermanium or etoposide only. One hundred and fourteen patients were registered for the study. Among 98 evaluable patients there were only two partial responses (both in the etoposide arm), and one complete response in the mitoxantrone arm. The median survival on the study was 3.3 months. One hundred and six patients were analyzable for toxicity. There were four treatment-related deaths and four life-threatening toxicities. Because of low response rates and relatively high toxicities the studied compounds were not deemed worth further investigation for advanced gastric cancer.


gastric cancer chemotherapy etoposide mitoxantrone spirrogermanium aclacinomycin A survival 


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  1. 1.
    Wils J. The treatment of advanced gastric cancer.Semin Oncol 1996;23(3): 397–406.PubMedGoogle Scholar
  2. 2.
    Glimelius B, Hoffman K, Haglund U. Initial or delayed chemotherapy with best supportive care in advanced gastric cancer.Ann Oncol 1994;5: 189–190.PubMedGoogle Scholar
  3. 3.
    Pyrhonen S, Kuitumen T, Kouri M. A randomized phase III triel comparing fluorouracil, epidoxorubicin and methotrexate (FEMTX) with best supportive care in non resectable gastric cancer (Abstract).Ann Oncol 1992;3(2): 12.Google Scholar
  4. 4.
    Nissen NI, Larsen V, Pedersen H, Thomsen K. Phase I clinical trial of a new anti-tumor agent NSC 141540, VP16-213.Cancer Chemother Rep 1972;56(6): 769–777.PubMedGoogle Scholar
  5. 5.
    Eagan RT, Carr DT, Frytak S, Rubin J, Lee RE. VP-16-213 versus polychemotherapy in patients with advanced small cell lung cancer.Cancer Treat Rep 1972;60: 949–951.Google Scholar
  6. 6.
    Kelsen DP, Magill R. Phase II trial of etoposide in the treatment of upper gastrointestinal tract malignancies.Cancer Treat Rep 1983;67: 509–513.PubMedGoogle Scholar
  7. 7.
    Kelsen DP, Buckner J. Phase II study of cisplatin and etoposide in adenocarcinoma of the stomach.Cancer Treat Rep 1987;71: 329–332.PubMedGoogle Scholar
  8. 8.
    McDonald JS, Havlin KA. Etoposide in gastric cancer.Semin Oncol 1992;19(6): Suppl. 13, S49-S62.Google Scholar
  9. 9.
    Asbury RFet al. An Eastern Cooperative Oncology Group phase II study of single agent DHAD, VP-16, aclacinomycin, or spirogermanium in metastatic pancreatic cancer.Am J Clin Oncol 1994;17(2): 166–169.PubMedCrossRefGoogle Scholar
  10. 10.
    Levi JA, Gill PG, Presgrave P. A phase II study of mitoxantrone in advanced gastric cancer.Invest New Drugs 1990;8(3): 305–306.PubMedCrossRefGoogle Scholar
  11. 11.
    Goldenberg A, Kelsen DP, Benedetto P. Phase II of mitoxantrone in advanced gastric cancer.Oncology 1988;56(4): 273–275.CrossRefGoogle Scholar
  12. 12.
    Ogawa Jet al. Clinical study of aclacinomycin A.Cancer Chemother Pharmacol 1978;1: 259–262.Google Scholar
  13. 13.
    Mathe Get al. Preliminary results of a Phase II trial of aclacinomycin in acute leukaemia and lymphosarcoma.Cancer Chemother Pharmacol 1978;1: 259–262.PubMedGoogle Scholar
  14. 14.
    Lad TEet al. Phase II Spirogermanium in advanced nonsmall cell lung cancer. An Illinois Cancer Council Study.Invest New Drugs 1989;30: 223–224.Google Scholar
  15. 15.
    Ettingerr DSet al. Phase II study of N-methylformamide, spirogermanium, a 4-demothoxydaunorubicin in the treatment of non-small cell lung cancer (EST 3583): An Eastern Cooperative Oncology Group Study.Med Pediatr Oncol 1989;17: 197–201CrossRefGoogle Scholar
  16. 16.
    Presser Pet al. Phase II Study with the combination of etoposide, doxorubixcin and cisplatin n advanced measurable gastric cancer.J Clin Oncol 1989;7: 1310–1317.Google Scholar
  17. 17.
    Wilke Het al. High dose folinic acid/etoposide/5-fluorouracil in advanced gastric cancer: A phase II study in elderly patients or patients with cardiac risk.Invest New Drugs 1990;8: 65–70.PubMedCrossRefGoogle Scholar

Copyright information

© Stockton Press All rights reserved 1999

Authors and Affiliations

  • Y Novik
    • 1
  • LM Ryan
    • 2
  • DG Haller
    • 3
  • R Asbury
    • 4
  • JP Dutcher
    • 1
  • A Schutt
    • 5
  1. 1.Comprehensive Cancer CenterOur Lady of Mercy Hospital, New York Medical CenterBronxUSA
  2. 2.Dana Farber Cancer InstituteBoston
  3. 3.University of Pennsylvania Cancer CenterPhiladelphia
  4. 4.Interlakes Oncology and Hematology, PCRochester
  5. 5.Mayo ClinicRochesterUSA

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