Target practice: oncology drug development in the era of genomic medicine

Bissett D. , O'Byrne KJ , von Pawel J. et al. Phase III study of matrix metalloproteinase inhibitor prinomastat in non—small-cell lung cancer. J Clin Oncol 2005; 23: 842—49.

Leighl NB , Paz-Ares L. , Douillard J-Y. et al. Randomized phase III study of matrix metalloproteinase inhibitor BMS-275291 in combination with paclitaxel and carboplatin in advanced non—small-cell lung cancer: National Cancer Institute of Canada-Clinical Trials Group Study BR.18 J Clin Oncol 2005; 23: 2831—39.

Moore MJ , Hamm J. , Dancey J. et al. Comparison of gemcitabine versus the matrix metalloproteinase inhibitor BAY 12-9566 in patients with advanced or metastatic adenocarcinoma of the pancreas: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 2003; 21: 3296—302.

Sparano JA , Bernardo P. , Stephenson P. et al. Randomized phase III trial of marimastat versus placebo in patients with metastatic breast cancer who have responding or stable disease after first-line chemotherapy: Eastern Cooperative Oncology Group Trial E2196. J Clin Oncol 2004; 22: 4683—90.

Mass RD , Press M. , Anderson S. , Murphy M. , Slamon D. Improved survival benefit from Herceptin (trastuzumab) in patients selected by Fluorescence in Situ Hybridization (FISH). Proc Am Soc Clin Oncol 2001; 20: (abstr 85).

Herbst RS , Giaccone G. , Schiller JH et al. Gefitinib in combination with paclitaxel and carboplatin in advanced non small cell lung cancer:a phase III trial-INTACT II. J Clin Oncol 2004; 22: 785—94.

Giaccone G. , Herbst JS , Manegold C. et al. Gefitinib in combination with gemcitabine and cisplatin in non small cell lung cancer: a phase III trial-INTACT I. J Clin Oncol 2004; 22: 777—84.

Lynch TJ , Bell DW , Sordella R. et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non—small-cell lung cancer to gefitnib . New Engl J Med 2004; 350: 2129—39.

Bell DW , Lynch TJ , Haserlat SM et al. Epidermal growth factor receptor mutations and gene amplification in non—small-cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J Clin Oncol 2005; 23: 8081—92.

Vogel CA , Cobleigh MH , Tripathy D. et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of Her-2 overexpressing metastatic breast cancer. J Clin Oncol 2002; 20:719—26.

Cunningham D. , Humblet Y. , Siena S. et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. New Engl J Med 2004; 351: 337—45.

Chung KY , Shia J. , Kemeny NE et al. Cetuximab shows activity in colorectal cancer tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol 2005; 23: 1803—10.

Stadler WM , Rosner G. , Small E. et al. Successful implementation of the randomized discontinuation trial design: an application to the study of the putative antiangiogenic agent carboxyaminoimidazole in renal cell carcinoma—CALGB 69901. J Clin Oncol 2005; 23: 3726—32.

Ratain MJ , Eisen T. , Stadler W. et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 2006; 24: 2505—12.

Rubinstein LV , Korn EL , Friedlin B. , Hunsberger S. , Ivy SP , Smith MA Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol 2006; 23: 7199—206.