-
1
-
-
79960239432
-
Designing phase II trials in cancer: A systematic review and guidance
-
Brown SR, Gregory WM, Twelves CJ, Buyse M, Collinson F, Parmar M, et al. Designing phase II trials in cancer: a systematic review and guidance. Br J Cancer 2011;105: 194-199.
-
(2011)
Br J Cancer
, vol.105
, pp. 194-199
-
-
Brown, S.R.1
Gregory, W.M.2
Twelves, C.J.3
Buyse, M.4
Collinson, F.5
Parmar, M.6
-
2
-
-
67650302854
-
Phase II trials in journal of clinical oncology
-
Cannistra SA. Phase II trials in journal of clinical oncology. J Clin Oncol 2009;27: 3073-3076.
-
(2009)
J Clin Oncol
, vol.27
, pp. 3073-3076
-
-
Cannistra, S.A.1
-
3
-
-
57849154374
-
Optimising the design of phase II oncology trials: The importance of randomization
-
Ratain MJ, Sargent DJ. Optimising the design of phase II oncology trials: the importance of randomization. Eur J Cancer 2009;45: 275-280.
-
(2009)
Eur J Cancer
, vol.45
, pp. 275-280
-
-
Ratain, M.J.1
Sargent, D.J.2
-
4
-
-
27244436755
-
Design issues of randomized phase II trials and a proposal for phase II screening trials
-
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: 7199-7206.
-
(2005)
J Clin Oncol
, vol.23
, pp. 7199-7206
-
-
Rubinstein, L.V.1
Korn, E.L.2
Freidlin, B.3
Hunsberger, S.4
Ivy, S.P.5
Smith, M.A.6
-
5
-
-
77951639219
-
Comparison of error rates in single-arm versus randomized phase II cancer clinical trials
-
Tang H, Foster NR, Grothey A, Ansell SM, Goldberg RM, Sargent DJ. Comparison of error rates in single-arm versus randomized phase II cancer clinical trials. J Clin Oncol 2010;28: 1936-41.
-
(2010)
J Clin Oncol
, vol.28
, pp. 1936-1941
-
-
Tang, H.1
Foster, N.R.2
Grothey, A.3
Ansell, S.M.4
Goldberg, R.M.5
Sargent, D.J.6
-
6
-
-
57849117384
-
New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
-
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45: 228-47.
-
(2009)
Eur J Cancer
, vol.45
, pp. 228-247
-
-
Eisenhauer, E.A.1
Therasse, P.2
Bogaerts, J.3
Schwartz, L.H.4
Sargent, D.5
Ford, R.6
-
7
-
-
63449114216
-
Randomized phase II designs
-
Rubinstein L, Crowley J, Ivy P, LeBlanc M, Sargent D. Randomized phase II designs. Clin Cancer Res 2009;15: 1883-90.
-
(2009)
Clin Cancer Res
, vol.15
, pp. 1883-1890
-
-
Rubinstein, L.1
Crowley, J.2
Ivy, P.3
Leblanc, M.4
Sargent, D.5
-
8
-
-
79960746726
-
Randomized phase II trials: A long-term investment with promising returns
-
Sharma MR, Stadler WM, Ratain MJ. Randomized phase II trials: a long-term investment with promising returns. J Natl Cancer Inst 2011;103: 1093-1100.
-
(2011)
J Natl Cancer Inst
, vol.103
, pp. 1093-1100
-
-
Sharma, M.R.1
Stadler, W.M.2
Ratain, M.J.3
-
9
-
-
35148821353
-
Design of phase II cancer trials using a continuous endpoint of change of tumor size: Application to a study of sorafenib and erlotinib in non small-cell lung cancer
-
Karrison TG, Maitland ML, Stadler WM, Ratain MJ. Design of phase II cancer trials using a continuous endpoint of change of tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. J Natl Cancer Inst 2007;99: 1455-61.
-
(2007)
J Natl Cancer Inst
, vol.99
, pp. 1455-1461
-
-
Karrison, T.G.1
Maitland, M.L.2
Stadler, W.M.3
Ratain, M.J.4
-
10
-
-
33744984843
-
Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma
-
Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, 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.
-
(2006)
J Clin Oncol
, vol.24
, pp. 2505-2512
-
-
Ratain, M.J.1
Eisen, T.2
Stadler, W.M.3
Flaherty, K.T.4
Kaye, S.B.5
Rosner, G.L.6
-
11
-
-
79957487708
-
Progression-free survival ratio as end point for phase II trials in advanced solid tumors
-
Buyse M, Quinaux E, Hendlisz A, Golfinopoulos V, Tournigand C, Mick R. Progression-free survival ratio as end point for phase II trials in advanced solid tumors. J Clin Oncol 2011;29:e451-e452.
-
(2011)
J Clin Oncol
, vol.29
-
-
Buyse, M.1
Quinaux, E.2
Hendlisz, A.3
Golfinopoulos, V.4
Tournigand, C.5
Mick, R.6
-
12
-
-
67651171223
-
Elucidation of relationship between tumor size and survival in nonsmall- cell lung cancer patients can aid early decision making in clinical drug development
-
Wang Y, Sung C, Dartois C, Ramchandani R, Booth BP, Rock E, et al. Elucidation of relationship between tumor size and survival in nonsmall- cell lung cancer patients can aid early decision making in clinical drug development. Clin Pharmacol Ther 2009;86: 167-74.
-
(2009)
Clin Pharmacol Ther
, vol.86
, pp. 167-174
-
-
Wang, Y.1
Sung, C.2
Dartois, C.3
Ramchandani, R.4
Booth, B.P.5
Rock, E.6
-
13
-
-
70249134646
-
Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics
-
Claret L, Girard P, Hoff PM, Van CutsemE, Zuideveld KP, Jorga K, et al. Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics. J Clin Oncol 2009;27: 4103-8.
-
(2009)
J Clin Oncol
, vol.27
, pp. 4103-4108
-
-
Claret, L.1
Girard, P.2
Hoff, P.M.3
Van Cutsem, E.4
Zuideveld, K.P.5
Jorga, K.6
-
14
-
-
67651162021
-
On the use of change in tumor size to predict survival in clinical oncology studies: Towards a new paradigm to design and evaluate phase II studies
-
Bruno R, Claret L. On the use of change in tumor size to predict survival in clinical oncology studies: towards a new paradigm to design and evaluate phase II studies. Clin Pharmacol Ther 2009;86: 136-8.
-
(2009)
Clin Pharmacol Ther
, vol.86
, pp. 136-138
-
-
Bruno, R.1
Claret, L.2
-
15
-
-
84872577506
-
Dynamic tumor modelling of the RECORD-1 phase II trial of everolimus quantifies relationship between dose and tumor growth in metastatic renal cell carcinoma
-
Stein A, Wang W, Carter A, Chiparus O, Hollaender N, Motzer R, et al. Dynamic tumor modelling of the RECORD-1 phase II trial of everolimus quantifies relationship between dose and tumor growth in metastatic renal cell carcinoma. Eur Urol Suppl 2011;10:232.
-
(2011)
Eur Urol Suppl
, vol.10
, pp. 232
-
-
Stein, A.1
Wang, W.2
Carter, A.3
Chiparus, O.4
Hollaender, N.5
Motzer, R.6
-
16
-
-
55049109179
-
Bevacizumab reduces the growth rate constants of renal carcinomas: A novel algorithm suggests early discontinuation of bevacizumab resulted in a lack of survival advantage
-
Stein WD, Yang J, Bates SE, Fojo T. Bevacizumab reduces the growth rate constants of renal carcinomas: A novel algorithm suggests early discontinuation of bevacizumab resulted in a lack of survival advantage. The Oncologist 2008;13: 1055-62.
-
(2008)
The Oncologist
, vol.13
, pp. 1055-1062
-
-
Stein, W.D.1
Yang, J.2
Bates, S.E.3
Fojo, T.4
-
17
-
-
70350139039
-
Other paradigms: Growth rate constants and tumor burden determined using computed tomography data correlate strongly with the overall survival of patients with renal cell carcinoma
-
Stein WD, Huang H, Menefee M, Edgerly M, Kotz H, Dwyer A, et al. Other paradigms: growth rate constants and tumor burden determined using computed tomography data correlate strongly with the overall survival of patients with renal cell carcinoma. Cancer J 2009;15: 441-7.
-
(2009)
Cancer J
, vol.15
, pp. 441-447
-
-
Stein, W.D.1
Huang, H.2
Menefee, M.3
Edgerly, M.4
Kotz, H.5
Dwyer, A.6
-
18
-
-
79951848170
-
Kinetic analysis of breast tumor decay and growth following ixabepilone plus capecitabine (IXA+ CAP) versus capecitabine alone (CAP) to discern whether the superiority of the combination is a result of slower growth, enhanced tumor cell kill, or both
-
(suppl; abstr 1096)
-
Fojo AT, Stein WD, Wilkerson J, Bates SE. Kinetic analysis of breast tumor decay and growth following ixabepilone plus capecitabine (IXA+ CAP) versus capecitabine alone (CAP) to discern whether the superiority of the combination is a result of slower growth, enhanced tumor cell kill, or both. J Clin Onc 28:15s, 2010 (suppl; abstr 1096).
-
(2010)
J Clin Onc
, vol.28
-
-
Fojo, A.T.1
Stein, W.D.2
Wilkerson, J.3
Bates, S.E.4
-
19
-
-
79953050574
-
Analysis of tumor burden versus progression-free survival for phase II decision making
-
Fridlyand J, Kaiser LD, Fyfe G. Analysis of tumor burden versus progression-free survival for phase II decision making. Contemp Clin Trials 2011;32: 446-52.
-
(2011)
Contemp Clin Trials
, vol.32
, pp. 446-452
-
-
Fridlyand, J.1
Kaiser, L.D.2
Fyfe, G.3
-
20
-
-
84859828707
-
Resampling phase III data to assess phase II trial designs and endpoints
-
Sharma MR, Karrison TG, Jin Y, Bies RR, Maitland ML, Stadler WM, et al. Resampling phase III data to assess phase II trial designs and endpoints. Clin Cancer Res 2012;18: 2309-15.
-
(2012)
Clin Cancer Res
, vol.18
, pp. 2309-2315
-
-
Sharma, M.R.1
Karrison, T.G.2
Jin, Y.3
Bies, R.R.4
Maitland, M.L.5
Stadler, W.M.6
-
21
-
-
2542561964
-
Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer
-
Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. NEngl J Med 2004;350: 2335-42.
-
(2004)
NEngl J Med
, vol.350
, pp. 2335-2342
-
-
Hurwitz, H.1
Fehrenbacher, L.2
Novotny, W.3
Cartwright, T.4
Hainsworth, J.5
Heim, W.6
-
22
-
-
20044364346
-
Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer
-
Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005;23: 792-9.
-
(2005)
J Clin Oncol
, vol.23
, pp. 792-799
-
-
Miller, K.D.1
Chap, L.I.2
Holmes, F.A.3
Cobleigh, M.A.4
Marcom, P.K.5
Fehrenbacher, L.6
-
23
-
-
20544478429
-
Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: Results of a randomized phase II trial
-
Kabbinavar FF, Schulz J, McCleod M, Patel T, Hamm JT, Hecht JR, et al. Addition of bevacizumab to bolus fluorouracil and leucovorin in first-line metastatic colorectal cancer: Results of a randomized phase II trial. J Clin Oncol 2005;23: 3697-705.
-
(2005)
J Clin Oncol
, vol.23
, pp. 3697-3705
-
-
Kabbinavar, F.F.1
Schulz, J.2
McCleod, M.3
Patel, T.4
Hamm, J.T.5
Hecht, J.R.6
-
24
-
-
0037096755
-
Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results
-
O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub J-P, Cervantes G, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results. J Clin Oncol 2002;20: 2812-23.
-
(2002)
J Clin Oncol
, vol.20
, pp. 2812-2823
-
-
O'Shaughnessy, J.1
Miles, D.2
Vukelja, S.3
Moiseyenko, V.4
Ayoub, J.-P.5
Cervantes, G.6
-
25
-
-
22044445517
-
Erlotinib in previously treated non-small-cell lung cancer
-
Shepherd FA, Pereira JR, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, et al. Erlotinib in previously treated non-small-cell lung cancer.NEngl J Med 2005;353: 123-32.
-
(2005)
NEngl J Med
, vol.353
, pp. 123-132
-
-
Shepherd, F.A.1
Pereira, J.R.2
Ciuleanu, T.3
Tan, E.H.4
Hirsh, V.5
Thongprasert, S.6
-
26
-
-
0035869407
-
Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2
-
Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344: 783-92.
-
(2001)
N Engl J Med
, vol.344
, pp. 783-792
-
-
Slamon, D.J.1
Leyland-Jones, B.2
Shak, S.3
Fuchs, H.4
Paton, V.5
Bajamonde, A.6
-
28
-
-
19044400906
-
Maximum likelihood estimation in nonlinear mixed effects models
-
Kuhn E, Lavielle M. Maximum likelihood estimation in nonlinear mixed effects models. Comput Stat Data Anal 2005;49: 1020-38.
-
(2005)
Comput Stat Data Anal
, vol.49
, pp. 1020-1038
-
-
Kuhn, E.1
Lavielle, M.2
-
30
-
-
71549143528
-
Detecting an overall survival benefit that is derived from progression-free survival
-
Broglio KR, Berry DA. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009;101: 1642-9.
-
(2009)
J Natl Cancer Inst
, vol.101
, pp. 1642-1649
-
-
Broglio, K.R.1
Berry, D.A.2
-
31
-
-
35148868544
-
Early average change in tumor size in a phase 2 trial: Efficient endpoint or false promise?
-
Rubinstein LV, Dancey JE, Korn EL, Smith MA, Wright JJ. Early average change in tumor size in a phase 2 trial: efficient endpoint or false promise? J Natl Cancer Inst 2007;99: 1422-3.
-
(2007)
J Natl Cancer Inst
, vol.99
, pp. 1422-1423
-
-
Rubinstein, L.V.1
Dancey, J.E.2
Korn, E.L.3
Smith, M.A.4
Wright, J.J.5
-
32
-
-
84872544699
-
Clinical importance of including new and nontarget lesion assessment of disease progression (PD) to predict overall survival (OS): Implications for randomized phase II study design
-
(suppl; abstr 2543)
-
Mietlowski WL, Bao W, Wood PA, Williams DE, El-Hashimy M, Sarr C, et al. Clinical importance of including new and nontarget lesion assessment of disease progression (PD) to predict overall survival (OS): implications for randomized phase II study design. J Clin Oncol 30:15s, 2012 (suppl; abstr 2543).
-
(2012)
J Clin Oncol
, vol.30
-
-
Mietlowski, W.L.1
Bao, W.2
Wood, P.A.3
Williams, D.E.4
El-Hashimy, M.5
Sarr, C.6
|