Skip to main content

Methodology of Phase II Clinical Trial in Cancer

  • Chapter
New Anticancer Drugs

Part of the book series: Recent Results in Cancer Research ((RECENTCANCER,volume 70))

Abstract

The phase II clinical trial in cancer patients represents an initial step in the investigation of the antitumor potential of new treatments. It is usually considered as a clinical screening designed according to a delicate compromise of the need for meaningful data weighed against exposing the patient to other treatments with possibly greater effectiveness. The definition of this compromise is subject to change resulting in continuous readaptations in the design of these trials.

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

Access this chapter

eBook
USD 16.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Ahmann, D. L., Bisel, H. F., Hahn, R. G., Eagan, R. T., Edmonson, J. H., Steinfeld, J. L., Tormey, D. C., Taylor, W. F.: An analysis of a multiple-drug program in the treatment of patients with advanced breast cancer utilizing 5-fluorouracil, cyclophosphamide and prednisone with or without vincristine. Cancer 36, 1925 (1975)

    Article  PubMed  CAS  Google Scholar 

  2. Brambilla, C., DeLena, M., Rossi, A., Valagussa, P., Bonadonna, G.: Response and survival in advanced breast cancer after two non-cross-resistant combinations. Br. Med. J. 801, 1976 I

    Article  Google Scholar 

  3. Canellos, G. P., Pocock, S. J., Taylor, S. G., Sears, M. E., Klaassen, D. J., Band, P. R.: Combination chemotherapy of metastatic breast carcinoma. Cancer 38, 1882 (1976)

    Article  PubMed  CAS  Google Scholar 

  4. Carbone, P. P., Krant, M. J., Miller, S. P., Hall, T. C., Schnider, B. I., Colsky, J., Horton, J., Hosley, H., Miller, J. M., Frei, E. III, Schneiderman, M.: The feasibility of using randomization schemes early in the clinical trials of new chemotherapeutic agents. Clin. Pharmacol. Ther. 6, 17 (1965)

    PubMed  CAS  Google Scholar 

  5. Carter, S. K.: Study design principles of the clinical evaluation of new drugs as developed by the chemotherapy program of the National Cancer Institute. In: The design of clinical trials in cancer therapy. Staquet, M. (ed.) Brussels: Editions Scientifique Europeennes; New York: Futura 1973, p. 242

    Google Scholar 

  6. Carter, S. K.: Cancer treatment today and its impact on drug development, with special emphasis on the phase II clinical trial. J. Natl. Cancer Inst. 57, 235 (1976)

    PubMed  CAS  Google Scholar 

  7. Carter, S. K.: Clinical trials in cancer chemotherapy. Cancer 40 [Suppl.], 544 (1977)

    Article  PubMed  CAS  Google Scholar 

  8. DeVita, V. T., Fisher, R. I., Young, R. C.: Treatment of diffuse histiocytic lymphomas: New opportunities for the future. In: Recent advances in cancer treatment. Tagnon, H., Staquet, M. (eds.) New York: Raven 1977, p. 39

    Google Scholar 

  9. Gehan, E. A.: The determination of the number of patients required in a preliminary and follow-up trial of a new chemotherapeutic agent. J. Chronic Dis. 13, 346 (1961)

    Article  PubMed  CAS  Google Scholar 

  10. Hoogstraten, B., George, S. L., Samal, B., Rivkin, S. E., Costanzi, J. J., Bonnet, J. D., Thigpen, T., Braine, H.: Combination chemotherapy and adriamycin in patients with advanced breast cancer. Cancer 38, 13 (1976)

    Article  PubMed  CAS  Google Scholar 

  11. Jacobs, E. M., Muggia, F. M., Rozencweig, M.: Chemotherapy of testicular cancer: From palliation to curative adjuvant therapy. Semin. Oncol. 6, 13 (1979)

    Google Scholar 

  12. Livingston, R. B., Moore, T. N., Heilbrun, L., Bottomley, R., Lehane, D., Rivkin, S. E., Thigpen, T.: Small-cell carcinoma of the lung: Combined chemotherapy and radiation. Ann. Intern. Med. 88, 194 (1978)

    PubMed  CAS  Google Scholar 

  13. Moertel, C.G., Hanley, J. A.: The effect of measuring error on the results of therapeutic trials in advanced cancer. Cancer 38, 388 (1976)

    Article  PubMed  CAS  Google Scholar 

  14. Rosenoff, S. H., DeVita, V. T., Hubbard, S., Young, R. C.: Peritoneoscopy in the staging and follow-up of ovarian cancer. Semin. Oncol. 2, 223 (1975)

    PubMed  CAS  Google Scholar 

  15. Staquet, M., Sylvester, R.: A decision theory approach to phase II clinical trials. Biomedicine 26, 262 (1977)

    PubMed  CAS  Google Scholar 

  16. Zelen, M.: Keynote address on biostatistics and data retrieval. Cancer Chemother. Rep. [Part 3] 4, 31 (1973)

    CAS  Google Scholar 

  17. Zelen, M.: Importance of prognostic factors in planning clinical trials. In: Cancer therapy: Prognostic factors and criteria of response. Staquet, M. (ed.) New York: Raven 1975, p. 1

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 1980 Springer-Verlag Berlin Heidelberg

About this chapter

Cite this chapter

Muggia, F.M., Rozencweig, M., Staquet, M.J., McGuire, W.P. (1980). Methodology of Phase II Clinical Trial in Cancer. In: Carter, S.K., Sakurai, Y. (eds) New Anticancer Drugs. Recent Results in Cancer Research, vol 70. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-81392-4_5

Download citation

  • DOI: https://doi.org/10.1007/978-3-642-81392-4_5

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-81394-8

  • Online ISBN: 978-3-642-81392-4

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics