Clinical Evaluation of Antitumor Therapy

1. Front Matter

   Pages i-xii

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2. General Issues in Anticancer Drug Development

   • Franco M. Muggia, Marcel Rozencweig

   Pages 3-16

3. Animal Tumor Models for Experimental Therapy

   • Luke M. van Putten

   Pages 17-31

4. Experimental Therapy: In Vitro Models

   • John D. Cowan, Daniel D. von Hoff

   Pages 33-53

5. Clinical Evaluation: Noninvasive Methods

   • Philip C. Hoffman, John E. Ultmann

   Pages 55-83

6. Clinical Evaluation: Biochemical Methods

   • Raymond W. Ruddon

   Pages 85-115

7. Anatomic and Surgical Principles in Cancer Clinical Trials

   • Thomas T. Kubota, William D. Dewys

   Pages 117-131

8. Experimental Toxicology

   • Patrick J. Creaven, Peter M. Kanter

   Pages 133-152

9. The Phase I Study: General Objectives, Methods, and Evaluation

   • Gerald P. Bodey, Sewa S. Legha

   Pages 153-174

10. Clinical Evaluation of Anticancer Treatments: Phase II Clinical Trials

    • Howard I. Scher, Nancy L. Geller, Franco M. Muggia, Marcel Rozencweig

    Pages 175-197

11. Analysis of Clinical Trial Data

    • Maurice J. Staquet, Stefan Suciu, Richard Sylvester

    Pages 199-210

12. The Strategy of Cancer Treatment

    • Stephen K. Carter

    Pages 211-216

13. Back Matter

    Pages 217-219

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The methodology of drug development has been the subject of extensive dis­ cussion by a relatively small group of individuals in industry and government who have been intimately concerned with the identification and study of new anticancer drugs. The Chemotherapy Program of the National Cancer In­ stitute has represented the major focus of initial efforts in drug development, as summarized in the historical perspective presented in chapter 1 and its references. It is no coincidence that the Chemotherapy Program was the origin of the Division of Cancer Treatment, a government entity that has had a pivotal role in the growth of clinical oncology. In an analogous fashion this book presents the methodology employed in the clinical study of anticancer drugs within the broad context of cancer treatment. The research orientation promulgated in the study of new drugs is a central theme in most oncolo­ gists' approach to the clinical problem of cancer. Therefore, we hope that this book will introduce readers to treatment research in clinical oncology. For the oncologist, the clinical evaluation of antitumor therapy is both part of the day-to-day management of specific patients and the critical considera­ tion of developing therapeutic alternatives. For physicians in other fields of medicine it is important to acquaint themselves with the basic tools of the oncologist. For people without medical training, including patients who might be interested in treatment research, many of the chapters may be overly technical.

• cancer
• cancer treatment
• chemotherapy
• clinical trial
• oncology
• tumor

• Norris Cancer Hospital, USC School of Medicine, USC Comprehensive Cancer Center, Los Angeles, USA

  Franco M. Muggia

• Pharmaceutical Research and Development Division, Bristol-Myers Company and New York University Medical Center, Syracuse, USA

  Marcel Rozencweig

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