Phase I Cancer Clinical Trials: A Practical Guide

Phase I Cancer Clinical Trials: A Practical Guide (2 ed.)

Edited by Elizabeth A. Eisenhauer, Christopher Twelves, and Marc Buyse

Abstract

Phase I trials are a critical first step in the study of novel cancer therapeutic approaches. Their primary goals are to identify the recommended dose, schedule and pharmacologic behavior of new agents or new combinations of agents and to describe the adverse effects of treatment. In cancer therapeutics, such studies have particular challenges. Due to the nature of the effects of treatment, most such studies are conducted in patients with advanced malignancy, rather than in healthy volunteers. Furthermore, the endpoints of these trials are usually measures adverse effects rather than molecular target or anti-tumor effects. These factors render the design, conduct, analysis and ethical aspects of phase I cancer trials unique. As the only comprehensive book on this topic, this online resource for oncology trainees and specialists explains cancer drug development and includes information on Phase 0 Trials, immunotherapeutics, and updated information on the process, pitfalls, and logistics of Phase I Trials.

Bibliographic Information

Publisher:: Oxford University Press

Print Publication Date:: Mar 2015

Print ISBN-13:: 9780199359011

Published online:: May 2015

DOI:: 10.1093/med/9780199359011.001.0001

Authors

Elizabeth A. Eisenhauer, editor Head, Department of Oncology; Medical Director, Oncology Program, Queen's University, Kingston General Hospital, Cancer Centre of Southeastern Ontario, Kingston, Ontario

Christopher Twelves, editor Professor of Clinical Pharmacology and Oncology; Head, Section of Clinical Cancer Research Groups, Leeds Institute of Molecular Medicine, St. James's Institute of Oncology, Leeds

Marc Buyse, editor Founder and Chairman; Associate Professor of Biostatistics, International Drug Development Institute; Universiteit Hasselt, Louvain-la-Neuve

Back to results

Disclaimer

Oxford University Press makes no representation, express or implied, that the drug dosages in this book are correct. Readers must therefore always check the product information and clinical procedures with the most up to date published product information and data sheets provided by the manufacturers and the most recent codes of conduct and safety regulations. The authors and the publishers do not accept responsibility or legal liability for any errors in the text or for the misuse or misapplication of material in this work. Except where otherwise stated, drug dosages and recommendations are for the non-pregnant adult who is not breastfeeding.

Access to the complete content on Oxford Medicine Online requires a subscription or purchase. Public users are able to search the site and view the abstracts for each book and chapter without a subscription.

Please subscribe or login to access full text content.

If you have purchased a print title that contains an access token, please see the token for information about how to register your code.

For questions on access or troubleshooting, please check our FAQs, and if you can't find the answer there, please contact us.

Front Matter
- Preface
- Contributors
1 IntroductionElizabeth A. Eisenhauer
2 Preclinical Data and RequirementsSophie Postel-Vinay, Jean-Charles Soria, and Elizabeth A. Eisenhauer
3 Phase 0 Clinical TrialsShivaani Kummar and James H. Doroshow
4 Basics of Phase I Design: First-in-Human StudiesDonna M. Graham, Aaron R. Hansen, Elizabeth A. Eisenhauer, and Lillian L. Siu
5 Ethical Issues in First-in-Human Phase I Cancer TrialsElizabeth A. Eisenhauer
6 Phase I Trials in Special Populations and CircumstancesRajiv Kumar, Chris Twelves, and Udai Banerji
7 Phase I Trials of ImmunotherapeuticsChristy Ralph, Emma King, Chris Twelves, and Christian Ottensmeier
8 Statistical Designs for First-in-Man Phase I Cancer TrialsXavier Paoletti and Marc Buyse
9 Writing the ProtocolPenelope A. Bradbury and Elizabeth A. Eisenhauer
10 Practical Aspects of Pharmacokinetics and PharmacodynamicsChris Twelves, Maria Jove, and Paul Loadman
11 Process, Pitfalls, and Logistics of Phase I TrialsElizabeth A. Eisenhauer, Chris Twelves, Hayley Farmer, and Philip Ross
12 Reporting and Interpreting Results Lesleigh S. Abbott, Elizabeth A. Eisenhauer, and Lesley K. Seymour
End Matter
- Appendix: Useful Web Resources
- Index

Select your specializations: Select All / Clear Selections

Phase I Cancer Clinical Trials: A Practical Guide (2 ed.)

Edited by Elizabeth A. Eisenhauer, Christopher Twelves, and Marc Buyse

Abstract

Bibliographic Information

Authors

Contents