Author Contributions: Dr Motzer, as principal investigator of this study, had full access to all of the study data and takes responsibility for the integrity of the data and the accuracy of the data analyses.
Study design and concept: Baum, Motzer.
Acquisition of data: Bukowski, Curti, George, Ginsberg, Hudes, Margolin, Merchan, Michaelson, Motzer, Redman, Rini, Wilding.
Drafting of the manuscript: Kim, Michaelson, Motzer.
Critical revision of the manuscript for important intellectual content: Bukowski, Curti, George, Ginsberg, Hudes, Margolin, Merchan, Michaelson, Motzer, Redman, Rini, Wilding.
Statistical expertise: Bacik (independent analysis).
Obtained funding: Baum, Kim.
Administrative, technical, or material support: Kim.
Study supervision: Baum, Kim, Motzer.
Patient measurement: Ginsberg.
Financial Disclosures: Dr Motzer has reported receiving research support from Pfizer. Dr Rini has reported receiving research support from Genentech, Bayer, and Pfizer and is a consultant for Bayer. Dr Bukowski has reported receiving research support from Pfizer, Bayer, Genentech, Amgen, and GlaxoSmithKline. He has also reported being a consultant for GlaxoSmithKline, Bayer, and Pfizer. Dr Michaelson has reported being a member of an advisory board for Pfizer. Drs Curti, George, Hudes, Redman, Margolin, Merchan, and Wilding have reported receiving research support from Pfizer. Ms Kim and Dr Baum are employees of Pfizer.
Funding/Support: Research support for this trial was provided by Pfizer Inc.
Role of the Sponsor: The funding and infrastructure to conduct this trial were provided by Pfizer Inc, which also provided the study drug and hired a contract research organization (PRA International, Charlottesville, Va) for data management and analyses. The data analyses were conducted by PRA International and were then given to Dr Motzer, along with the individual patient data.
Independent Statistical Analysis: Jennifer Bacik, statistician, Memorial Sloan-Kettering Cancer Center, New York, NY, performed an independent statistical analysis of the raw data set. The analysis confirmed all results reported in this article. Ms Bacik did not receive any compensation for her work.
Participating Investigators, Research Coordinators, and Institutions: Memorial Sloan-Kettering Cancer Center, New York, NY (Dr Motzer, principal investigator; Patricia Fischer, RN, research nurse; Suzanne M. Sweeney, RN, research nurse; Asia McCoy, BA, data manager); University of California, San Francisco, San Francisco (Dr Rini, investigator; Doug Hutcheon, BS, research coordinator); Cleveland Clinic Foundation, Cleveland, Ohio (Dr Bukowski, investigator; Laura Wood, RN, MSN, OCN, research nurse); Robert W. Franz Cancer Center, Portland, Ore (Dr Curti, investigator; Lisa Justice, RN, research nurse); Duke University Medical Center, Durham, NC (Dr George, investigator; Patricia Creel, RN, OCN, research nurse); Fox Chase Cancer Center, Philadelphia, Pa (Dr Hudes, investigator; Lois Malizzia, RN, OCN, research nurse); University of Michigan, Ann Arbor (Dr Redman, investigator; Peg Esper, RN, MSN, research nurse); City of Hope National Medical Center, Duarte, Calif (Dr Margolin, investigator; Mary Carroll, RN, research nurse); Mayo Clinic, Rochester, Minn (Dr Merchan, investigator; Kathleen M. Liffrig, oncology coordinator; Kerri Milbrandt, RN, BSN, research nurse); University of Wisconsin Comprehensive Cancer Center, Madison (Dr Wilding, investigator); Massachusetts General Hospital, Boston (Dr Michaelson, investigator; Beverly Spicer, RN, research nurse; Nicole Barry, BA, data manager).
Previous Presentation: Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology; May 13-17, 2005; Orlando, Fla.
Acknowledgment: Writing and editorial support was provided by Rachel Mason, medical writer, ACUMED. Ms Mason was compensated by Pfizer Inc. Independent third-party assessment was performed by a third-party core imaging laboratory (RadPharm, Princeton, NJ).