A Comparison of Phase II Study Strategies

被引：29

作者：

Hunsberger, Sally ^{[1
]}

Zhao, Yingdong ^{[1
]}

Simon, Richard ^{[1
]}

机构：

[1] NCI, Biometr Res Branch, Div Canc Treatment & Diag, Bethesda, MD 20892 USA

来源：

CLINICAL CANCER RESEARCH | 2009年 / 15卷 / 19期

关键词：

ADVANCED PANCREATIC-CANCER; SAMPLE-SIZE CONSIDERATIONS; CLINICAL-TRIAL DESIGNS; GEMCITABINE; OXALIPLATIN; COMBINATION; CARCINOMA; CISPLATIN; GERCOR; AGENTS;

D O I：

10.1158/1078-0432.CCR-08-3205

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The traditional oncology drug development paradigm of single arm phase II studies followed by a randomized phase III study has limitations for modern oncology drug development. Interpretation of single arm phase II study results is difficult when a new drug is used in combination with other agents or when progression-free survival is used as the endpoint rather than tumor shrinkage. Randomized phase II studies are more informative for these objectives but increase both the number of patients and time required to determine the value of a new experimental agent. In this article, we compare different phase II study strategies to determine the most efficient drug development path in terms of number of patients and length of time to conclusion of drug efficacy on overall survival. (Clin Cancer Res 2009;15(19):5950-5)

引用

页码：5950 / 5955

页数：6

共 21 条

[1] EVALUATION OF EXPERIMENTS WITH ADAPTIVE INTERIM ANALYSES [J].

BAUER, P ;

KOHNE, K .

BIOMETRICS, 1994, 50 (04) :1029-1041

[2] SAMPLE-SIZE CONSIDERATIONS FOR STUDIES COMPARING SURVIVAL CURVES USING HISTORICAL CONTROLS [J].

DIXON, DO ;

SIMON, R .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 1988, 41 (12) :1209-1213

[3] Interim futility analysis with intermediate endpoints [J].

Goldman, Bryan ;

LeBlanc, Michael ;

Crowley, John .

CLINICAL TRIALS, 2008, 5 (01) :14-22

[4]

Green Stephanie., 1997, Clinical Trials in Oncology

[5] Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer [J].

Heinemann, Volker ;

Quietzsch, Detlef ;

Gieseler, Frank ;

Gonnermann, Michael ;

Schoenekaes, Herbert ;

Rost, Andreas ;

Neuhaus, Horst ;

Haag, Caroline ;

Clemens, Michael ;

Heinrich, Bernard ;

Vehling-Kaiser, Ursula ;

Fuchs, Martin ;

Fleckenstein, Doris ;

Gesierich, Wolfgang ;

Uthgenannt, Dirk ;

Einsele, Hermann ;

Holstege, Axel ;

Hinke, Axel ;

Schalhorn, Andreas ;

Wilkowski, Ralf .

JOURNAL OF CLINICAL ONCOLOGY, 2006, 24 (24) :3946-3952

[6] Seamlessly expanding a randomized phase II trial to phase III [J].

Inoue, LYT ;

Thall, PF ;

Berry, DA .

BIOMETRICS, 2002, 58 (04) :823-831

[7] USING THE TOLERABLE-DOSE DIAGRAM IN THE DESIGN OF PHASE-I COMBINATION CHEMOTHERAPY TRIALS [J].

KORN, EL ;

SIMON, R .

JOURNAL OF CLINICAL ONCOLOGY, 1993, 11 (04) :794-801

[8] Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate [J].

Lima, CMR ;

Green, MR ;

Rotche, R ;

Miller, WH ;

Jeffrey, GM ;

Cisar, LA ;

Morganti, A ;

Orlando, N ;

Gruia, G ;

Miller, LL .

JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (18) :3776-3783

[9] Gemcitabine combined with oxaliplatin in advanced pancreatic adenocarcinoma:: Final results of a GERCOR multicenter phase II study [J].

Louvet, C ;

André, T ;

Lledo, G ;

Hammel, P ;

Bleiberg, H ;

Bouleuc, C ;

Gamelin, E ;

Flesch, M ;

Cvitkovic, E ;

de Gramont, A .

JOURNAL OF CLINICAL ONCOLOGY, 2002, 20 (06) :1512-1518

[10] Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer:: Results of a GERCOR and GISCAD phase III trial [J].

Louvet, C ;

Labianca, R ;

Hammel, P ;

Lledo, G ;

Zampino, MG ;

André, T ;

Zaniboni, A ;

Ducreux, M ;

Aitini, E ;

Taïeb, J ;

Faroux, R ;

Lepere, C ;

de Gramont, A .

JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (15) :3509-3516

← 1 2 3 →