Are Phase 2 screening trials in Oncology obsolete?

Statistics in Medicine

Volumn 27, Issue 4, 2008, Pages 556-567

  Holmgren, Eric ^a  

^a GENENTECH INC   (United States)

Author keywords

Clinical development; Phase 2; Phase 3; Screening studies

Indexed keywords

BEVACIZUMAB; PLACEBO;

ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED STUDY; DRUG EFFICACY; DRUG MEGADOSE; DRUG RESEARCH; HAZARD RATIO; HUMAN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MATHEMATICAL COMPUTING; MORTALITY; PHASE 2 CLINICAL TRIAL; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE;

CLINICAL TRIALS, PHASE II AS TOPIC; DRUG EVALUATION; HUMANS; MASS SCREENING; MEDICAL ONCOLOGY; MODELS, STATISTICAL;

EID: 39449098422     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2989     Document Type: Article

References (8)

1. Korn EL et al. Clinical trial designs for cytostatic agents: are new approaches needed? Journal of Clinical Oncology 2001; 19(1):265-272.
2. Gray R et al. Phase II clinical trial design: methods in translational research from the genitourinary committee at the eastern cooperative oncology group. Clinical Cancer Research 2006; 12(7):1966-1969, DOI: 10.1158/1078-0432.CCR-05-1136.
3. Kabbinavar F et al. Phase II, randomized trial comparing bevacizumab plus fluorouracil (fu)/leucovorin (lv) with fu/lv alone in patients with metastatic colorectal cancer. Journal of Clinical Oncology 2003; 21(1):60-65. DOI: 10.1200/JCO.2003.10.066.
4. Hurwitz H et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. The New England Journal of Medicine 2004; 350(23):2335-2342.
5. Von Hoff D. There are no bad anticancer agents, only bad clinical trial designs - twenty-first Richard and Hinda Rosenthal foundation award lecture. Clinical Cancer Research 1998; 4:1079-1086.
6. DiMasi J et al. The price of innovation: new estimates of drug development costs. Journal of Health Economics 2003; 22:151-185. DOI: 10.1016/S0167-6296(02)00126-1.
7. Reddy GK. The addition of bevacizumab to FOLFOX4 prolongs survival in relapsed colorectal cancer: interim data from the ECOG 3200 trial. Clinical Colorectal Cancer 2005; 4(5):300-301.
8. Sandler A et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. The New England Journal of Medicine 2006; 355(24):2542-2550.