Skip to main content

Advertisement

Log in

Phase II Studies

Phase II trial of menogaril as initial chemotherapy for metastatic breast cancer

  • Published:
Investigational New Drugs Aims and scope Submit manuscript

Summary

Eighteen women with metastatic breast cancer previously untreated with chemotherapy were entered on a phase II trial of intravenous menogaril, a new anthracycline derivative. Treatment was given at 140 mg/m2 on days 1 and 8 of each 28 day cycle. The most common toxicities were leukopenia in all patients and burning and phlebitis at infusion sites in 72%. Serial assessment of cardiac function by resting and stress gated blood pool scans showed temporary decrements in ejection fraction in only 2 patients (11%). The response rate to the therapy was 19% [95% CI 0–38%] including 1 complete and 2 partial responses. The median time to relapse among responders was 6.5 months. Mean survival in all patients entered was 15.8 months from date of entry. Menogaril at this dose and schedule has modest activity as first line therapy for metastatic breast cancer but also has significant marrow and local toxicity.

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

Access this article

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

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Henderson IC: Chemotherapy for Advanced Disease. In: Bonadonna G. (ed) Breast Cancer; Diagnosis and Management. John Wiley and Sons, New York, 1984; 247–280

    Google Scholar 

  2. Weiss GR, Von Hoff DD, McGovren JP, Neil GL, Paque RE: Antitumor activity of 7-con-O-methylnogarol (7-OMEN) in the human tumor clonogenic assay (Abstr). Proc Am Assoc Cancer Res 24: 309, 1983

    Google Scholar 

  3. Neil GL, Kuentzel SL, McGovren JP: Treatment of mouse tumors with 7-con-O-methylnogarol and other analogs of the anthracycline antibiotic, nogalamycin. Cancer Treat Rep 63: 1971–1978, 1979

    Google Scholar 

  4. McGovren JP, Neil GL, Denlinger RH, Hall TL, Crampton SL, Swenberg JA: Chronic cardiotoxicity studies in rabbits with 7-con-O-methylnogarol, a new anthracycline antitumor agent. Cancer Res 39: 4849–4855, 1979

    Google Scholar 

  5. Brown TD, Donehower RC, Grochow LB, Rice AP, Ettinger DS: A Phase I Study of Menogaril in Patients with Advanced Cancer. J Clin Oncol 5: 92–99, 1987

    Google Scholar 

  6. Oken MM, Creech RH, Tormey DC, Horton J, Davis MD, McFadden ET, Carbone PP: Toxicity and response criteria of the Eastern Co-operative Oncology Group. Am J Clin Oncol 5: 649–655, 1982

    CAS  PubMed  Google Scholar 

  7. Gottlieb J, Rivkin S, Spiegel SC, Hoogstraten B, O'Bryan R, Delaney FC, Singhakowinta A: Superiority of adriamycin over oral nitrosurea in patients with advanced breast cancer: Cancer 33: 519–526, 1974

    Google Scholar 

  8. Tormey DC: Adriamycin (NSC-123127) in breast cancer: An overview of studies. Cancer Chemother Rep 6: 319–327, 1975

    Google Scholar 

  9. Sessa C, Gunderson S, ten Bokkel-Huinink W, Renard J, Cavalli F: Phase II Study of Intravenous Menogaril in Patients with Advanced Breast Cancer. J Natl Cancer Inst 80: 1066–1069, 1988

    Google Scholar 

  10. Long HJ, Schaid DJ, Schutt AJ, Ingle JN, Loprinzc C, Edmondson JH: Phase II evaluation of Menogaril in women with metastatic breast cancer after failure of first line chemotherapy (Abstr) Proc Am Assoc Cancer Res 28: 198, 1987

    Google Scholar 

  11. Dodion P, Sessa C, Joss R, Crespeigne N, Williams Y, Kitt M, Abrams J, Finet C, Brewer JE, Adams WJ, Earhart RH, Rozencweig M, Kenis Y, Cavalli F: Phase I study of Intravenous Menogaril Administered Intermittently. J Clin Oncol 4: 767–774, 1986

    Google Scholar 

  12. Costanza ME, Korzun AH, Norton L, Rice MA, Wood WC: A fair trial of trimetrexate (TMTX) in advanced breast cancer (Abstr) Breast Cancer Res and Treat 12: 125, 1988

    Google Scholar 

  13. Joss RA, Monfardini S, Hansen M, Dombernowsky P, Renard J, Pinedo HM: Negative Phase II Trial of Menogaril in Squamous, Adeno- and Large Cell Carcinoma of the Lung. Eur J Cancer Clin Oncol 24: 263–265, 1988

    Google Scholar 

  14. Gunderson S, Monfardini S, Renard J, Van Glabbeke M, Pinedo H: Phase II Trial of Menogaril in Advanced Malignant Melanoma. An EORTC Trial. Eur J Cancer Clin Oncol 23: 1707–1708, 1987

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Rights and permissions

Reprints and permissions

About this article

Cite this article

Kennedy, M.J., Donehower, R.C., Grochow, L.B. et al. Phase II Studies. Invest New Drugs 8, 289–294 (1990). https://doi.org/10.1007/BF00171839

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF00171839

Key words

Navigation