Skip to main content
SpringerLink
Log in

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

  • Original Paper
  • Published:
Medical Oncology Aims and scope Submit manuscript

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Wils J. The treatment of advanced gastric cancer.Semin Oncol 1996;23(3): 397–406.

    CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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. 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.

    CAS  PubMed  Google Scholar 

  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. Kelsen DP, Magill R. Phase II trial of etoposide in the treatment of upper gastrointestinal tract malignancies.Cancer Treat Rep 1983;67: 509–513.

    CAS  PubMed  Google Scholar 

  7. Kelsen DP, Buckner J. Phase II study of cisplatin and etoposide in adenocarcinoma of the stomach.Cancer Treat Rep 1987;71: 329–332.

    CAS  PubMed  Google Scholar 

  8. McDonald JS, Havlin KA. Etoposide in gastric cancer.Semin Oncol 1992;19(6): Suppl. 13, S49-S62.

    Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  11. Goldenberg A, Kelsen DP, Benedetto P. Phase II of mitoxantrone in advanced gastric cancer.Oncology 1988;56(4): 273–275.

    Article  Google Scholar 

  12. Ogawa Jet al. Clinical study of aclacinomycin A.Cancer Chemother Pharmacol 1978;1: 259–262.

    Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  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: 197–201

    Article  Google Scholar 

  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.

    Article  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Comprehensive Cancer Center, Our Lady of Mercy Hospital, New York Medical Center, 600 E233rd Street, 10466, Bronx, New York, USA

    Y Novik MD & JP Dutcher

  2. Dana Farber Cancer Institute, Boston, Massachusetts

    LM Ryan

  3. University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania

    DG Haller

  4. Interlakes Oncology and Hematology, PC, Rochester, New York

    R Asbury

  5. Mayo Clinic, Rochester, Minnesota, USA

    A Schutt

Authors
  1. Y Novik MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. LM Ryan
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. DG Haller
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. R Asbury
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. JP Dutcher
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. A Schutt
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Y Novik MD.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Novik, Y., Ryan, L., Haller, D. et al. Phase II protocol for the evaluation of new treatments in patients with advanced gastric carcinoma: results of ECOG 5282. Med Oncol 16, 261–266 (1999). https://doi.org/10.1007/BF02785872

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02785872

Keywords

Search

Navigation