-
1
-
-
0036554730
-
End points in cancer clinical trials and the drug approval process
-
Schilsky RL: End points in cancer clinical trials and the drug approval process. Clin Cancer Res 8:935-938, 2002
-
(2002)
Clin Cancer Res
, vol.8
, pp. 935-938
-
-
Schilsky, R.L.1
-
2
-
-
68949145130
-
Personalizing cancer care: American Society of Clinical Oncology presidential address 2009
-
Schilsky RL: Personalizing cancer care: American Society of Clinical Oncology presidential address 2009. J Clin Oncol 27:3725-3730, 2009
-
(2009)
J Clin Oncol
, vol.27
, pp. 3725-3730
-
-
Schilsky, R.L.1
-
4
-
-
0031671255
-
Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer
-
Cocconi G, Cunningham D, Van Cutsem E, et al: Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. J Clin Oncol 16:2943-2952, 1998 (Pubitemid 28417413)
-
(1998)
Journal of Clinical Oncology
, vol.16
, Issue.9
, pp. 2943-2952
-
-
Cocconi, G.1
Cunningham, D.2
Van Cutsem, E.3
Francois, E.4
Gustavsson, B.5
Van Hazel, G.6
Kerr, D.7
Possinger, K.8
Hietschold, S.M.9
-
5
-
-
0033874892
-
Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer
-
de Gramont A, Figer A, Seymour M, et al: Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18:2938-2947, 2000
-
(2000)
J Clin Oncol
, vol.18
, pp. 2938-2947
-
-
De Gramont, A.1
Figer, A.2
Seymour, M.3
-
6
-
-
0034712536
-
Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial
-
Douillard JY, Cunningham D, Roth AD, et al: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial. Lancet 355:1041-1047, 2000
-
(2000)
Lancet
, vol.355
, pp. 1041-1047
-
-
Douillard, J.Y.1
Cunningham, D.2
Roth, A.D.3
-
7
-
-
0034727063
-
Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer: Irinotecan Study Group
-
Saltz LB, Cox JV, Blanke C, et al: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer: Irinotecan Study Group. N Engl J Med 343:905-914, 2000
-
(2000)
N Engl J Med
, vol.343
, pp. 905-914
-
-
Saltz, L.B.1
Cox, J.V.2
Blanke, C.3
-
8
-
-
0035871538
-
Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study
-
Hoff PM, Ansari R, Batist G, et al: Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study. J Clin Oncol 19:2282-2292, 2001 (Pubitemid 32366981)
-
(2001)
Journal of Clinical Oncology
, vol.19
, Issue.8
, pp. 2282-2292
-
-
Hoff, P.M.1
Ansari, R.2
Batist, G.3
Cox, J.4
Kocha, W.5
Kuperminc, M.6
Maroun, J.7
Walde, D.8
Weaver, C.9
Harrison, E.10
Burger, H.U.11
Osterwalder, B.12
Wong, A.O.13
Wong, R.14
-
9
-
-
0035503151
-
Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: Results of a large phase III study
-
Van Cutsem E, Twelves C, Cassidy J, et al: Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: Results of a large phase III study. J Clin Oncol 19:4097-4106, 2001
-
(2001)
J Clin Oncol
, vol.19
, pp. 4097-4106
-
-
Van Cutsem, E.1
Twelves, C.2
Cassidy, J.3
-
10
-
-
0036727089
-
Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer
-
DOI 10.1200/JCO.2002.10.129
-
Carmichael J, Popiela T, David Radstone D, et al: Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 20:3617-3627, 2002 (Pubitemid 34983221)
-
(2002)
Journal of Clinical Oncology
, vol.20
, Issue.17
, pp. 3617-3627
-
-
Carmichael, J.1
Popiela, T.2
Radstone, D.3
Falk, S.4
Borner, M.5
Oza, A.6
Skovsgaard, T.7
Munier, S.8
Martin, C.9
-
11
-
-
0036731818
-
Multicenter phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer
-
Douillard JY, Paulo M, Hoff PM, et al: Multicenter phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer J Clin Oncol 20:3605-3616, 2002
-
(2002)
J Clin Oncol
, vol.20
, pp. 3605-3616
-
-
Douillard, J.Y.1
Paulo, M.2
Hoff, P.M.3
-
12
-
-
2542561964
-
Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer
-
DOI 10.1056/NEJMoa032691
-
Hurwitz H, Fehrenbacher L, Novotny W, et al: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342, 2004 (Pubitemid 38702844)
-
(2004)
New England Journal of Medicine
, vol.350
, Issue.23
, pp. 2335-2342
-
-
Hurwitz, H.1
Fehrenbacher, L.2
Novotny, W.3
Cartwright, T.4
Hainsworth, J.5
Heim, W.6
Berlin, J.7
Baron, A.8
Griffing, S.9
Holmgren, E.10
Ferrara, N.11
Fyfe, G.12
Rogers, B.13
Ross, R.14
Kabbinavar, F.15
-
13
-
-
1642539160
-
FDA Drug Approval Summaries: Oxaliplatin
-
DOI 10.1634/theoncologist.9-1-8
-
Ibrahim A, Hirschfeld S, Cohen MH, et al: FDA drug approval summaries: Oxaliplatin. Oncologist 9:8-12, 2004 (Pubitemid 38134009)
-
(2004)
Oncologist
, vol.9
, Issue.1
, pp. 8-12
-
-
Ibrahim, A.1
Hirschfeld, S.2
Cohen, M.H.3
Griebel, D.J.4
Williams, G.A.5
Pazdur, R.6
-
14
-
-
1842569206
-
A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer
-
Goldberg RM, Sargent DJ, Morton RF, et al: A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22:23-30, 2004
-
(2004)
J Clin Oncol
, vol.22
, pp. 23-30
-
-
Goldberg, R.M.1
Sargent, D.J.2
Morton, R.F.3
-
15
-
-
47249146141
-
Lessons from Tarceva in pancreatic cancer: Where are we now, and how should future trials be designed in pancreatic cancer?
-
Laurent-Puig P, Taieb J: Lessons from Tarceva in pancreatic cancer: Where are we now, and how should future trials be designed in pancreatic cancer? Curr Opin Oncol 20:454-458, 2008
-
(2008)
Curr Opin Oncol
, vol.20
, pp. 454-458
-
-
Laurent-Puig, P.1
Taieb, J.2
-
16
-
-
36849078044
-
Progression-free survival is a surrogate for survival in advanced colorectal cancer
-
DOI 10.1200/JCO.2007.11.8836
-
Buyse M, Burzykowski T, Carroll K, et al: Progression-free survival is a surrogate for survival in advanced colorectal cancer. J Clin Oncol 25:5218-5224, 2007 (Pubitemid 350232253)
-
(2007)
Journal of Clinical Oncology
, vol.25
, Issue.33
, pp. 5218-5224
-
-
Buyse, M.1
Burzykowski, T.2
Carroll, K.3
Michiels, S.4
Sargent, D.J.5
Miller, L.L.6
Elfring, G.L.7
Pignon, J.-P.8
Piedbois, P.9
-
17
-
-
42949113031
-
Assessing the measure of a new drug: Is survival the only thing that matters?
-
Sargent DJ, Hayes DF: Assessing the measure of a new drug: Is survival the only thing that matters? J Clin Oncol 26:1922-1923, 2008
-
(2008)
J Clin Oncol
, vol.26
, pp. 1922-1923
-
-
Sargent, D.J.1
Hayes, D.F.2
-
18
-
-
42949145995
-
Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer
-
Burzykowski T, Buyse M, Piccart-Gebhart MJ, et al: Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer. J Clin Oncol 26:1987-1992, 2008
-
(2008)
J Clin Oncol
, vol.26
, pp. 1987-1992
-
-
Burzykowski, T.1
Buyse, M.2
Piccart-Gebhart, M.J.3
-
20
-
-
67649990278
-
Issues in using progression-free survival when evaluating oncology products
-
Fleming TR, Rothmann MD, Lu HL: Issues in using progression-free survival when evaluating oncology products. J Clin Oncol 27:2874-2880, 2009
-
(2009)
J Clin Oncol
, vol.27
, pp. 2874-2880
-
-
Fleming, T.R.1
Rothmann, M.D.2
Lu, H.L.3
-
21
-
-
33644843853
-
OPTIMOX1: A randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-go fashion in advanced colorectal cancer-a GERCOR study
-
Tournigand C, Cervantes A, Figer A, et al: OPTIMOX1: A randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-go fashion in advanced colorectal cancer-a GERCOR study. J Clin Oncol 24:394-400, 2006
-
(2006)
J Clin Oncol
, vol.24
, pp. 394-400
-
-
Tournigand, C.1
Cervantes, A.2
Figer, A.3
-
22
-
-
73349089651
-
Can chemotherapy be discontinued in unresectable metastatic colorectal cancer?: The GERCOR OPTIMOX2 study
-
Chibaudel B, Maindrault-Goebel F, Lledo G, et al: Can chemotherapy be discontinued in unresectable metastatic colorectal cancer?: The GERCOR OPTIMOX2 study. J Clin Oncol 27:5727-5733, 2009
-
(2009)
J Clin Oncol
, vol.27
, pp. 5727-5733
-
-
Chibaudel, B.1
Maindrault-Goebel, F.2
Lledo, G.3
-
23
-
-
33750925368
-
Alternating versus continuous "FOLFIRI" in advanced colorectal cancer: A randomized "GISCAD" trial
-
Labianca R, Floriani I, Cortesi E, et al: Alternating versus continuous "FOLFIRI" in advanced colorectal cancer: A randomized "GISCAD" trial. J Clin Oncol 24:147s, 2006 (suppl 3505)
-
(2006)
J Clin Oncol
, vol.24
, Issue.SUPPL. 3505
-
-
Labianca, R.1
Floriani, I.2
Cortesi, E.3
-
24
-
-
69849108427
-
Clinical trial designs for predictive biomarker validation: Theoretical considerations and practical challenges
-
Mandrekar SJ, Sargent DJ: Clinical trial designs for predictive biomarker validation: Theoretical considerations and practical challenges. J Clin Oncol 27:4027-4034, 2009
-
(2009)
J Clin Oncol
, vol.27
, pp. 4027-4034
-
-
Mandrekar, S.J.1
Sargent, D.J.2
-
25
-
-
41649102043
-
The cancer biomarker problem
-
Sawyers CL: The cancer biomarker problem. Nature 452:548-552, 2008
-
(2008)
Nature
, vol.452
, pp. 548-552
-
-
Sawyers, C.L.1
-
26
-
-
33749647287
-
Meta-analyses of adjuvant therapies for women with early breast cancer: The Early Breast Cancer Trialists' Collaborative Group overview
-
Clarke M: Meta-analyses of adjuvant therapies for women with early breast cancer: The Early Breast Cancer Trialists' Collaborative Group overview. Ann Oncol 17:S59-S62, 2006 (suppl 10)
-
(2006)
Ann Oncol
, vol.17
, Issue.SUPPL. 10
-
-
Clarke, M.1
-
27
-
-
47949101334
-
Clinical biomarkers of kinase activity: Examples from EGFR inhibition trials
-
Krause M, Baumann M: Clinical biomarkers of kinase activity: Examples from EGFR inhibition trials. Cancer Metastasis Rev 27:387-402, 2008
-
(2008)
Cancer Metastasis Rev
, vol.27
, pp. 387-402
-
-
Krause, M.1
Baumann, M.2
-
28
-
-
34247278727
-
Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy
-
Di Fiore F, Blanchard F, Charbonnier F, et al: Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy. Br J Cancer 96:1166-1169, 2007
-
(2007)
Br J Cancer
, vol.96
, pp. 1166-1169
-
-
Di Fiore, F.1
Blanchard, F.2
Charbonnier, F.3
-
29
-
-
42649145667
-
Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer
-
Amado RG, Wolf M, Peeters M, et al: Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 26:1626-1634, 2008
-
(2008)
J Clin Oncol
, vol.26
, pp. 1626-1634
-
-
Amado, R.G.1
Wolf, M.2
Peeters, M.3
-
30
-
-
66849140563
-
PTEN expression and KRAS mutations on primary tumors and metastases in the prediction of benefit from cetuximab plus irinotecan for patients with metastatic colorectal cancer
-
Loupakis F, Pollina L, Stasi I, et al: PTEN expression and KRAS mutations on primary tumors and metastases in the prediction of benefit from cetuximab plus irinotecan for patients with metastatic colorectal cancer. J Clin Oncol 27:2622-2629, 2009
-
(2009)
J Clin Oncol
, vol.27
, pp. 2622-2629
-
-
Loupakis, F.1
Pollina, L.2
Stasi, I.3
-
31
-
-
44249108138
-
Anti-VEGF therapy: The search for clinical biomarkers
-
DOI 10.1586/14737159.8.3.301
-
Longo R, Gasparini G: Anti-VEGF therapy: The search for clinical biomarkers. Expert Rev Mol Diagn 8:301-314, 2008 (Pubitemid 351724709)
-
(2008)
Expert Review of Molecular Diagnostics
, vol.8
, Issue.3
, pp. 301-314
-
-
Longo, R.1
Gasparini, G.2
-
32
-
-
38349160711
-
The Biomarkers Consortium: On the critical path of drug discovery
-
Altar CA: The Biomarkers Consortium: On the critical path of drug discovery. Clin Pharmacol Ther 83:361-364, 2008
-
(2008)
Clin Pharmacol Ther
, vol.83
, pp. 361-364
-
-
Altar, C.A.1
-
33
-
-
74549144459
-
-
US Food and Drug Administration: FDA Critical Path Initiative. http://www.fda.gov/oc/initiatives/criticalpath
-
FDA Critical Path Initiative
-
-
-
34
-
-
39649084919
-
The FDA critical path initiative and its influence on new drug development
-
DOI 10.1146/annurev.med.59.090506.155819
-
Woodcock J, Woosley R: The FDA critical path initiative and its influence on new drug development. Annu Rev Med 59:1-12, 2008 (Pubitemid 351287920)
-
(2008)
Annual Review of Medicine
, vol.59
, pp. 1-12
-
-
Woodcock, J.1
Woosley, R.2
-
35
-
-
33644834827
-
Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: Individual patient data from 20,898 patients on 18 randomized trials
-
Sargent DJ, Wieand HS, Haller DG, et al: Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: Individual patient data from 20,898 patients on 18 randomized trials. J Clin Oncol 23:8664-8670, 2005
-
(2005)
J Clin Oncol
, vol.23
, pp. 8664-8670
-
-
Sargent, D.J.1
Wieand, H.S.2
Haller, D.G.3
-
36
-
-
34748918347
-
Controversies of adjuvant endocrine treatment for breast cancer and recommendations of the 2007 St Gallen conference
-
Rabaglio M, Aebi S, Castiglione-Gertsch M: Controversies of adjuvant endocrine treatment for breast cancer and recommendations of the 2007 St Gallen conference. Lancet Oncol 8:940-949, 2007
-
(2007)
Lancet Oncol
, vol.8
, pp. 940-949
-
-
Rabaglio, M.1
Aebi, S.2
Castiglione-Gertsch, M.3
-
37
-
-
84871468704
-
-
National Cancer Institute. http://www.cancer.gov/researchandfunding
-
-
-
-
38
-
-
33947275414
-
NCI's cancer therapy evaluation program: A commitment to treatment trials
-
Leong SPL (ed): New York, NY, Springer
-
Abrams JD, Murgo A, Christian MC: NCI's cancer therapy evaluation program: A commitment to treatment trials, in Leong SPL (ed): Cancer Clinical Trials: Proactive Strategies. New York, NY, Springer, 2007, pp 32-50
-
(2007)
Cancer Clinical Trials: Proactive Strategies
, pp. 32-50
-
-
Abrams, J.D.1
Murgo, A.2
Christian, M.C.3
-
39
-
-
35648964774
-
End points for colon cancer adjuvant trials: Observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT group
-
DOI 10.1200/JCO.2006.10.4323
-
Sargent DJ, Patiyil S, Yothers G: End points for colon cancer adjuvant trials: Observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group. J Clin Oncol 25:4569-4574, 2007 (Pubitemid 350035314)
-
(2007)
Journal of Clinical Oncology
, vol.25
, Issue.29
, pp. 4569-4574
-
-
Sargent, D.J.1
Patiyil, S.2
Yothers, G.3
Haller, D.G.4
Gray, R.5
Benedetti, J.6
Buyse, M.7
Labianca, R.8
Seitz, J.F.9
O'Callaghan, C.J.10
Francini, G.11
Grothey, A.12
O'Connell, M.13
Catalano, P.J.14
Kerr, D.15
Green, E.16
Wieand, H.S.17
Goldberg, R.M.18
De Gramont, A.19
|