References

1. Hanahan D, Weinberg R. The hallmarks of cancer. Cell 2000; 100(1):57- 70.

2. Geller N. Design of phase I and phase II clinical trials in cancer: a statistician's view. Cancer Invest 1984; 2:483-491.

3. Storer BE. Design and analysis of phase I clinical trials. Biometrics 1989; 45(3):925 - 937.

4. Korn EL, Midthune D, Chen TT, Rubinstein LV, Simon RM. A comparison of two phase I trial designs. Stat Med 1994; 13(18):1799-1806.

5. Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collin J, Christian MC. Accelerated titration designs for phase I clinical trials in oncology. JNCI 1997; 89(15):1138-1147.

6. Ivanova A, Montazer-Haghighi A, Mohanty SG, Durham SD. Improved up-and-down designs for phase I trials. Stat Med 2003; 22:69 - 82.

7. Gezmu M. The Geometric Up-and-Down Design for Allocating Dosage Levels. Dissertation, American University, 1996.

8. Narayana TV. Sequential Procedures in the Probit Analysis. Dissertation, University of North Carolina, Chapel Hill, 1953.

9. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics 1990; 45:33 -48.

10. Chevret S. The continual reassessment method in cancer phase I clinical trials: a simulation study. Stat Med 1993; 12:1093-1108.

11. Goodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med 1995; 14:1149-1161.

12. Moller S. An extension of the continual reassessment methods using a preliminary up-and-down design in a dose-finding study in cancer patients, in order to investigate a greater range of doses. Stat Med 1995; 14:911-922.

13. Korn EL, Arbuck SG, Pluda JM, Simon R, Kaplan RS, Christian MC. Clinical trial designs for cytostatic agents: are new approaches needed? J Clin Onc 2001; 19(1): 265-272.

14. Parulekar WR, Eisenhauer EA. Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: theory and practice. JNCI 2004; 96(13):990-997.

15. Ranson M, Jayson G. Targeted antitumor therapy-future perspective. British Journal of Cancer 2005; 92(suppl 1):S28-S31.

16. Ma BB, Britten CD, Siu LL. Clinical trial designs for targeted agents. Hematol Oncol Clin North Am 2002; 16(5):1287-1305.

17. Rowinsky E. The pursuit of optimal outcomes in cancer therapy in a new age of rationally designed target-based anti-cancer agents. Drugs 2000; 60(suppl 1):1 -14.

18. Gelmon KA, Eisenhauer EA, Harris AL, Ratain M, Workman P. Anticancer agents targeting signaling molecules and cancer cell development: challenges for drug development? JNCI 1999; 91(15):1281-1287.

19. Hunsberger S, Rubinstein LV, Dancey J, Korn EL. Dose escalation trial designs based on molecularly targeted endpoint. Stat Med 2005; 24:2171-2181.

20. Thall PF, Estey E, Sung H. A new statistical method for dose-finding based on efficacy and toxicity in early phase clinical trial. Invest New Drugs 1999; 17:155-167.

21. Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics 2004; 60(3):684- 693.

22. Zhang W, Sargent DJ, Mandrekar S. An adaptive dose-finding design incorporating both toxicity and efficacy. Stat Med 2005; 25(14):2365-2383.

23. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10:1-10.

24. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38(1):143-151.

25. Dent S, Zee B, Dancey J, Hanauske A, Wanders J, Eisenhauer E. Application of a new multinomial phase II stopping rule using response and early progression. J Clin Oncol 2001; 19(3):785-791.

26. Zee B, Melnychuk D, Dancey J, Eisenhauer E. Multinomial phase II cancer trials incorporating response and early progression. J Biopharm Stat 1999; 9(2):351-363.

27. Von Hoff DD. There are no bad anticancer agents, only bad clinical trial designs— twenty-first Richard and Hinda Rosenthal Foundation Award Lecture. Clin Cancer Res 1998; 4(5):1079-1086.

28. Chan S, Scheulen ME, Johnston S, et al. Phase II study of temsirolimus (CCI-779), a novel inhibitor of mTOR, in heavily pretreated patients with locally advanced or metastatic breast cancer. J Clin Oncol 2005; 23(23):5314-5322.

29. Perez EA, Geeraerts L, Suman VJ, et al. A randomized phase II study of sequential docetaxel and doxorubicin/cyclophosphamide in patients with metastatic breast cancer. Ann Oncol 2002; 13(8):1225-1235.

30. Herson J, Carter SK. Calibrated phase II clinical trials in oncology. Stat Med 1986; 5(5):441-447.

Rubinstein LV, Korn EL, Freidlin 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 2005; 23(28):7199 - 7206.

Simon R, Wittes RE, Ellenberg SS. Randomized phase II clinical trials. Cancer Treat Rep 1985; 69(12):1375-1381.

Sargent DJ, Goldberg RM. A flexible design for multiple armed screening trials. Stat Med 2001; 20(7):1051-1060.

Thall PF, Simon R, Ellenberg SS. A two-stage design for choosing among several experimental treatments and a control in clinical trials. Biometrics 1989; 45(2):537-547. Strauss N, Simon R. Investigating a sequence of randomized phase II trials to discover promising treatments. Stat Med 1995; 14:1479-1489.

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(16):3726-3732.

Freidlin B, Simon R. Evaluation of randomized discontinuation design. J Clin Oncol 2005; 23(22):5094-5098.

Wieand HS. Randomized phase II trials: what does randomization gain? J Clin Oncol 2005; 23(9):1794-1795.

Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res 2004; 10(20):6759-6763.

Maitournam A, Simon R. On the efficiency of targeted clinical trials. Stat Med 2005; 24(3):329-339.

Loi S, Buyse M, Sotiriou C, Cardoso F. Challenges in breast cancer clinical trial design in the postgenomic era. Curr Opin Oncol 2004; 16:536-541.

Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344(11):783-792.

Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005; 353(16):1673-1684. 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 2. J Clin Oncol 2004; 22(5):785 - 794.

Giaccone G, Herbst RS, Manegold C, et al. Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial-INTACT 1. J Clin Oncol 2004; 22(5):777- 784.

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 gefitinib. N Engl J Med 2004; 350(21):2129-2139.

Cunningham D, Humblet Y, Siena S, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351(4):337-345.

Chung KY, Shia J, Kemeny NE, et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immu-nohistochemistry. J Clin Oncol 2005; 23(9):1803-1810.

Saltz LB. Can the addition of cetuximab to irinotecan improve outcome in colorectal cancer? Nat Clin Pract Oncol 2005; 2(1):20-21.

Sargent DJ, Conley BA, Allegra C, Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol 2005; 23(9):2020-2027. Hecht JR, Trarbach T, Jaeger E, et al. A randomized, double-blind, placebo-controlled, phase III study in patients (pts) with metastatic adenocarcinoma of the colon or rectum receiving first-line chemotherapy with oxaliplatin/5-fluorouracil/leucovorin and PTK787/ZK 222584 or placebo (CONFIRM-1). J Clin Oncol, 2005 ASCO Annual Meeting Proceedings, 2005; 23(16S):3.

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