-
1
-
-
0035154256
-
Clinical trial designs for cytostatic agents: Are new approaches needed?
-
Korn EL, Arbuck SG, Pluda JM, et al. Clinical trial designs for cytostatic agents: are new approaches needed? J Clin Oncol. 2001;19:265-272.
-
(2001)
J Clin Oncol
, vol.19
, pp. 265-272
-
-
Korn, E.L.1
Arbuck, S.G.2
Pluda, J.M.3
-
2
-
-
0035868647
-
Clinical trial designs for the early clinical development of therapeutic cancer vaccines
-
Simon RM, Steinberg SM, Hamilton M, et al. Clinical trial designs for the early clinical development of therapeutic cancer vaccines. J Clin Oncol. 2001;19:1848-1854.
-
(2001)
J Clin Oncol
, vol.19
, pp. 1848-1854
-
-
Simon, R.M.1
Steinberg, S.M.2
Hamilton, M.3
-
3
-
-
0037818705
-
New designs for phase II clinical trials
-
Estey EH, Thall PF. New designs for phase II clinical trials. Blood. 2003; 102:442-448.
-
(2003)
Blood
, vol.102
, pp. 442-448
-
-
Estey, E.H.1
Thall, P.F.2
-
4
-
-
0036210050
-
Non-randomised phase II trials of drug combinations: Often meaningless, sometimes misleading. Are there alternative strategies?
-
Van Glabbeke M, Steward W, Armand JP, et al. Non-randomised phase II trials of drug combinations: often meaningless, sometimes misleading. Are there alternative strategies? Eur J Cancer. 2002;38:635- 638.
-
(2002)
Eur J Cancer
, vol.38
, pp. 635-638
-
-
Van Glabbeke, M.1
Steward, W.2
Armand, J.P.3
-
5
-
-
15744381413
-
Randomized phase II trials: What does randomization gain?
-
Wieand HS. Randomized phase II trials: what does randomization gain? J Clin Oncol. 2005;23:1794-1795.
-
(2005)
J Clin Oncol
, vol.23
, pp. 1794-1795
-
-
Wieand, H.S.1
-
6
-
-
27244440177
-
Comparison of outcomes of phase II studies and subsequent randomized controlled studies using identical chemotherapeutic regimens
-
Zia MI, Siu LL, Pond GR, et al. Comparison of outcomes of phase II studies and subsequent randomized controlled studies using identical chemotherapeutic regimens. J Clin Oncol. 2005;23:6982-6991.
-
(2005)
J Clin Oncol
, vol.23
, pp. 6982-6991
-
-
Zia, M.I.1
Siu, L.L.2
Pond, G.R.3
-
7
-
-
32944478346
-
Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer
-
Kindler HL, Friberg G, Singh DA, et al. Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2005;23:8033-8040.
-
(2005)
J Clin Oncol
, vol.23
, pp. 8033-8040
-
-
Kindler, H.L.1
Friberg, G.2
Singh, D.A.3
-
8
-
-
34047179153
-
A double-blind, placebocontrolled, randomized phase III trial of gemcitabine (G) plus bevacizumab (B) versus gemcitabine plus placebo (P) in patients (pts) with advanced pancreatic cancer (PC): A preliminary analysis of Cancer and Leukemia Group B (CALGB) 80303
-
abstract 108
-
Kindler HL, Niedzwiecki D, Hollis D, et al. A double-blind, placebocontrolled, randomized phase III trial of gemcitabine (G) plus bevacizumab (B) versus gemcitabine plus placebo (P) in patients (pts) with advanced pancreatic cancer (PC): a preliminary analysis of Cancer and Leukemia Group B (CALGB) 80303. Proc Gastrointestinal Cancer Symposium. 2007; abstract 108.
-
(2007)
Proc Gastrointestinal Cancer Symposium
-
-
Kindler, H.L.1
Niedzwiecki, D.2
Hollis, D.3
-
9
-
-
0141688333
-
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
-
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: 3296-3302.
-
(2003)
J Clin Oncol
, vol.21
, pp. 3296-3302
-
-
Moore, M.J.1
Hamm, J.2
Dancey, J.3
-
10
-
-
2342645506
-
Phase III trial of gemcitabine plus tipifarnib compared with gemcitabine plus placebo in advanced pancreatic cancer
-
Van Cutsem E, van de Velde H, Karasek P, et al. Phase III trial of gemcitabine plus tipifarnib compared with gemcitabine plus placebo in advanced pancreatic cancer. J Clin Oncol. 2004;22:1430-1438.
-
(2004)
J Clin Oncol
, vol.22
, pp. 1430-1438
-
-
Van Cutsem, E.1
van de Velde, H.2
Karasek, P.3
-
11
-
-
1542503746
-
Phase III clinical trial of gefitinib, an epidermal growth factor receptor inhibitor, in combination with gemcitibine and cisplatin in advanced non-small-cell lung cancer: INTACT 1
-
Giaccone G, Herbst RS, Manegold C, et al. Phase III clinical trial of gefitinib, an epidermal growth factor receptor inhibitor, in combination with gemcitibine and cisplatin in advanced non-small-cell lung cancer: INTACT 1. J Clin Oncol. 2004;22:777-784.
-
(2004)
J Clin Oncol
, vol.22
, pp. 777-784
-
-
Giaccone, G.1
Herbst, R.S.2
Manegold, C.3
-
12
-
-
1542713370
-
Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: A phase III trial-INTACT 2
-
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;22:785-794.
-
(2004)
J Clin Oncol
, vol.22
, pp. 785-794
-
-
Herbst, R.S.1
Giaccone, G.2
Schiller, J.H.3
-
13
-
-
0036224539
-
Gemcitabine in metastatic nasopharyngeal carcinoma of the undifferentiated type
-
Foo KF, Tan EH, Leong SS, et al. Gemcitabine in metastatic nasopharyngeal carcinoma of the undifferentiated type. Ann Oncol. 2002;13:150 -156.
-
(2002)
Ann Oncol
, vol.13
, pp. 150-156
-
-
Foo, K.F.1
Tan, E.H.2
Leong, S.S.3
-
14
-
-
0037128665
-
A Bayesian re-assessment of two phase II trials of gemcitabine in metastatic nasopharyngeal cancer
-
Tan SB, Machin D, Tai BC, et al. A Bayesian re-assessment of two phase II trials of gemcitabine in metastatic nasopharyngeal cancer. Br J Cancer. 2002;86:843-850.
-
(2002)
Br J Cancer
, vol.86
, pp. 843-850
-
-
Tan, S.B.1
Machin, D.2
Tai, B.C.3
-
15
-
-
33748620963
-
-
Tan SB, Machin D. Phase II trial designs in the presence of stratification. Stat Med. 2006;25:3220-3222; author reply, 3222-3223.
-
Tan SB, Machin D. Phase II trial designs in the presence of stratification. Stat Med. 2006;25:3220-3222; author reply, 3222-3223.
-
-
-
-
16
-
-
1342289780
-
The phase III candidate: Can we improve the science of selection?
-
Bajorin D. The phase III candidate: can we improve the science of selection? J Clin Oncol. 2004;22:211-213.
-
(2004)
J Clin Oncol
, vol.22
, pp. 211-213
-
-
Bajorin, D.1
-
17
-
-
0037256345
-
-
Verbel DA, Kelly WK, Smaletz O, et al. Estimating survival benefit in castrate metastatic prostate cancer: decision making in proceeding to a definitive phase III trial. Urology. 2003;61:142-144.
-
Verbel DA, Kelly WK, Smaletz O, et al. Estimating survival benefit in castrate metastatic prostate cancer: decision making in proceeding to a definitive phase III trial. Urology. 2003;61:142-144.
-
-
-
-
18
-
-
0033920380
-
Phase II clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint
-
Mick R, Crowley JJ, Carroll RJ. Phase II clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint. Control Clin Trials. 2000;21:343-359.
-
(2000)
Control Clin Trials
, vol.21
, pp. 343-359
-
-
Mick, R.1
Crowley, J.J.2
Carroll, R.J.3
-
19
-
-
33749333699
-
Standard versus adaptive monitoring procedures: A commentary
-
Fleming TR. Standard versus adaptive monitoring procedures: a commentary. Stat Med. 2006;25:3305-3312.
-
(2006)
Stat Med
, vol.25
, pp. 3305-3312
-
-
Fleming, T.R.1
-
20
-
-
0032887956
-
Long-term survival in metastatic transitional-cell carcinoma and prognostic factors predicting outcome of therapy
-
Bajorin DF, Dodd PM, Mazumdar M, et al. Long-term survival in metastatic transitional-cell carcinoma and prognostic factors predicting outcome of therapy. J Clin Oncol. 1999;17:3173-3181.
-
(1999)
J Clin Oncol
, vol.17
, pp. 3173-3181
-
-
Bajorin, D.F.1
Dodd, P.M.2
Mazumdar, M.3
-
21
-
-
4444369379
-
Gemcitabine and carboplatin combination as first-line treatment in elderly patients and those unfit for cisplatin-based chemotherapy with advanced bladder carcinoma: Phase II study of the Hellenic Co-operative Oncology Group
-
Linardou H, Aravantinos G, Efstathiou E, et al. Gemcitabine and carboplatin combination as first-line treatment in elderly patients and those unfit for cisplatin-based chemotherapy with advanced bladder carcinoma: phase II study of the Hellenic Co-operative Oncology Group. Urology. 2004;64:479-484.
-
(2004)
Urology
, vol.64
, pp. 479-484
-
-
Linardou, H.1
Aravantinos, G.2
Efstathiou, E.3
-
22
-
-
0345381984
-
Gemcitabine and carboplatin in advanced transitional cell carcinoma of the urinary tract: An alternative therapy
-
Nogue-Aliguer M, Carles J, Arrivi A, et al. Gemcitabine and carboplatin in advanced transitional cell carcinoma of the urinary tract: an alternative therapy. Cancer. 2003;97:2180-2186.
-
(2003)
Cancer
, vol.97
, pp. 2180-2186
-
-
Nogue-Aliguer, M.1
Carles, J.2
Arrivi, A.3
-
23
-
-
0035339940
-
Combination paclitaxel, carboplatin, and gemcitabine is an active treatment for advanced urothelial cancer
-
Hussain M, Vaishampayan U, Du W, et al. Combination paclitaxel, carboplatin, and gemcitabine is an active treatment for advanced urothelial cancer. J Clin Oncol. 2001;19:2527-2533.
-
(2001)
J Clin Oncol
, vol.19
, pp. 2527-2533
-
-
Hussain, M.1
Vaishampayan, U.2
Du, W.3
-
24
-
-
22344447501
-
Randomized phase II designs in cancer clinical trials: Current status and future directions
-
Lee JJ, Feng L. Randomized phase II designs in cancer clinical trials: current status and future directions. J Clin Oncol. 2005;23:4450-4457.
-
(2005)
J Clin Oncol
, vol.23
, pp. 4450-4457
-
-
Lee, J.J.1
Feng, L.2
-
25
-
-
33845588585
-
Improving the design of phase II trials of cytostatic anticancer agents
-
Stone A, Wheeler C, Barge A. Improving the design of phase II trials of cytostatic anticancer agents. Contemp Clin Trials. 2007;28:138 -145.
-
(2007)
Contemp Clin Trials
, vol.28
, pp. 138-145
-
-
Stone, A.1
Wheeler, C.2
Barge, A.3
-
27
-
-
0033035719
-
False positive rates of randomized phase II designs
-
Liu PY, LeBlanc M, Desai M. False positive rates of randomized phase II designs. Control Clin Trials. 1999;20:343-352.
-
(1999)
Control Clin Trials
, vol.20
, pp. 343-352
-
-
Liu, P.Y.1
LeBlanc, M.2
Desai, M.3
-
28
-
-
3943051978
-
Some design issues in trials of microbicides for the prevention of HIV infection
-
Fleming TR, Richardson BA. Some design issues in trials of microbicides for the prevention of HIV infection. J Infect Dis. 2004;190:666-674.
-
(2004)
J Infect Dis
, vol.190
, pp. 666-674
-
-
Fleming, T.R.1
Richardson, B.A.2
-
29
-
-
0037112181
-
Randomized discontinuation design: Application to cytostatic antineoplastic agents
-
Rosner GL, Stadler W, Ratain MJ. Randomized discontinuation design: application to cytostatic antineoplastic agents. J Clin Oncol. 2002;20:4478 -4484.
-
(2002)
J Clin Oncol
, vol.20
, pp. 4478-4484
-
-
Rosner, G.L.1
Stadler, W.2
Ratain, M.J.3
-
30
-
-
1542351250
-
Comparing the power of the discontinuation design to that of the classic randomized design on time-to-event endpoints
-
Capra WB. Comparing the power of the discontinuation design to that of the classic randomized design on time-to-event endpoints. Control Clin Trials. 2004;25:168-177.
-
(2004)
Control Clin Trials
, vol.25
, pp. 168-177
-
-
Capra, W.B.1
-
31
-
-
24644438754
-
Evaluation of randomized discontinuation design
-
Freidlin B, Simon R. Evaluation of randomized discontinuation design. J Clin Oncol. 2005;23:5094-5098.
-
(2005)
J Clin Oncol
, vol.23
, pp. 5094-5098
-
-
Freidlin, B.1
Simon, R.2
-
32
-
-
33750600001
-
Problems with the randomized discontinuation design
-
Sonpavde G, Hutson TE, Galsky MD, et al. Problems with the randomized discontinuation design. J Clin Oncol. 2006;24:4669-4670.
-
(2006)
J Clin Oncol
, vol.24
, pp. 4669-4670
-
-
Sonpavde, G.1
Hutson, T.E.2
Galsky, M.D.3
-
34
-
-
0034666030
-
Phase I-II study of paclitaxel, cisplatin, and gemcitabine in advanced transitional-cell carcinoma of the urothelium. Spanish Oncology Genitourinary Group
-
Bellmunt J, Guillem V, Paz-Ares L, et al. Phase I-II study of paclitaxel, cisplatin, and gemcitabine in advanced transitional-cell carcinoma of the urothelium. Spanish Oncology Genitourinary Group. J Clin Oncol. 2000;18: 3247-3255.
-
(2000)
J Clin Oncol
, vol.18
, pp. 3247-3255
-
-
Bellmunt, J.1
Guillem, V.2
Paz-Ares, L.3
-
35
-
-
0043169600
-
New drugs and new approaches in metastatic bladder cancer
-
Bellmunt J, de Wit R, Albiol S, et al. New drugs and new approaches in metastatic bladder cancer. Crit Rev Oncol Hematol. 2003;47:195-206.
-
(2003)
Crit Rev Oncol Hematol
, vol.47
, pp. 195-206
-
-
Bellmunt, J.1
de Wit, R.2
Albiol, S.3
-
36
-
-
67749150451
-
-
Bellmunt J, von der Maase H, Mead GM, et al. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy; EORTC30987/Intergroup Study. J Clin Oncol. 2007 ASCO Annual Meeting Proceedings 25 (18S): LBA5030.
-
Bellmunt J, von der Maase H, Mead GM, et al. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy; EORTC30987/Intergroup Study. J Clin Oncol. 2007 ASCO Annual Meeting Proceedings 25 (18S): LBA5030.
-
-
-
-
37
-
-
0037208558
-
Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer
-
Beer TM, Eilers KM, Garzotto M, et al. Weekly high-dose calcitriol and docetaxel in metastatic androgen-independent prostate cancer. J Clin Oncol. 2003;21:123-128.
-
(2003)
J Clin Oncol
, vol.21
, pp. 123-128
-
-
Beer, T.M.1
Eilers, K.M.2
Garzotto, M.3
-
38
-
-
33947610197
-
Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: A report from the ASCENT Investigators
-
Beer TM, Ryan CW, Venner PM, et al. Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: a report from the ASCENT Investigators. J Clin Oncol. 2007;25:669-674.
-
(2007)
J Clin Oncol
, vol.25
, pp. 669-674
-
-
Beer, T.M.1
Ryan, C.W.2
Venner, P.M.3
-
39
-
-
67749151881
-
-
Novacea press release, November 5, 2007.
-
Novacea press release, November 5, 2007.
-
-
-
-
40
-
-
4744366279
-
Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer
-
Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512.
-
(2004)
N Engl J Med
, vol.351
, pp. 1502-1512
-
-
Tannock, I.F.1
de Wit, R.2
Berry, W.R.3
-
41
-
-
4744337716
-
Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer
-
Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351:1513-1520.
-
(2004)
N Engl J Med
, vol.351
, pp. 1513-1520
-
-
Petrylak, D.P.1
Tangen, C.M.2
Hussain, M.H.3
|