Randomized Phase II Trials: Inevitable or Inadvisable?

被引:65
作者
Gan, Hui K.
Grothey, Axel
Pond, Gregory R.
Moore, Malcolm J.
Siu, Lillian L. [1 ]
Sargent, Daniel
机构
[1] Princess Margaret Hosp, Div Med Oncol Haematol, Toronto, ON M5G 2M9, Canada
关键词
ADVANCED PANCREATIC-CANCER; DOSE RATE INFUSION; CLINICAL-TRIALS; PLUS GEMCITABINE; 30-MINUTE INFUSION; DESIGN ISSUES; CARCINOMA; FUTURE; MULTICENTER; OXALIPLATIN;
D O I
10.1200/JCO.2009.26.3343
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
[No abstract available]
引用
收藏
页码:2641 / 2647
页数:7
相关论文
共 46 条
[1]   Randomized phase III study of exatecan and gemcitabine compared with gemcitabine alone in untreated advanced pancreatic cancer [J].
Abou-Alfa, Ghassan K. ;
Letourneau, Richard ;
Harker, Graydon ;
Modiano, Manuel ;
Hurwitz, Herbert ;
Tchekmedyian, Nerses Simon ;
Feit, Kevie ;
Ackerman, Judie ;
De Jager, Robert L. ;
Eckhardt, S. Gail ;
O'Reilly, Eileen M. .
JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (27) :4441-4447
[2]   Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer [J].
Amado, Rafael G. ;
Wolf, Michael ;
Peeters, Marc ;
Van Cutsem, Eric ;
Siena, Salvatore ;
Freeman, Daniel J. ;
Juan, Todd ;
Sikorski, Robert ;
Suggs, Sid ;
Radinsky, Robert ;
Patterson, Scott D. ;
Chang, David D. .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (10) :1626-1634
[3]  
[Anonymous], DRUGS FDA
[4]   Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297 [J].
Berlin, JD ;
Catalano, P ;
Thomas, JP ;
Kugler, JW ;
Haller, DG ;
Benson, AB .
JOURNAL OF CLINICAL ONCOLOGY, 2002, 20 (15) :3270-3275
[5]   Influence of unrecognized molecular heterogeneity on randomized clinical trials [J].
Betensky, RA ;
Louis, DN ;
Cairncross, JG .
JOURNAL OF CLINICAL ONCOLOGY, 2002, 20 (10) :2495-2499
[6]   Phase II Trials in Journal of Clinical Oncology [J].
Cannistra, Stephen A. .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (19) :3073-3076
[7]   Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma - A prospective, randomized phase III study of the Gruppo Oncologico dell'Italia Meridionale [J].
Colucci, G ;
Giuliani, F ;
Gebbia, V ;
Biglietto, M ;
Rabitti, P ;
Uomo, G ;
Cigolari, S ;
Testa, A ;
Maiello, E ;
Lopez, M .
CANCER, 2002, 94 (04) :902-910
[8]   The price of innovation: new estimates of drug development costs [J].
DiMasi, JA ;
Hansen, RW ;
Grabowski, HG .
JOURNAL OF HEALTH ECONOMICS, 2003, 22 (02) :151-185
[9]   Economics of new oncology drug development [J].
DiMasi, Joseph A. ;
Grabowski, Henry G. .
JOURNAL OF CLINICAL ONCOLOGY, 2007, 25 (02) :209-216
[10]   Treatment success in cancer [J].
Djulbegovic, Berijamin ;
Kumar, Ambuj ;
Soares, Heloisa P. ;
Hozo, Iztok ;
Bepler, Gerold ;
Clarke, Mike ;
Bennett, Charles L. .
ARCHIVES OF INTERNAL MEDICINE, 2008, 168 (06) :632-642