메뉴 건너뛰기




Volumn 32, Issue 2, 2009, Pages 216-219

Patient selection for phase II trials

Author keywords

Patient selection; Phase II trial

Indexed keywords

CALCITRIOL; CARBOPLATIN; CISPLATIN; CORTICOSTEROID; DOCETAXEL; GEMCITABINE; MITOXANTRONE; PACLITAXEL;

EID: 67749104038     PISSN: 02773732     EISSN: 1537453X     Source Type: Journal    
DOI: 10.1097/COC.0b013e318172dccd     Document Type: Review
Times cited : (5)

References (41)
  • 1
    • 0035154256 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • Novacea press release, November 5, 2007.
    • Novacea press release, November 5, 2007.
  • 40
    • 4744366279 scopus 로고    scopus 로고
    • 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 scopus 로고    scopus 로고
    • 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


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.