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  • 1
    Simon R. Designs for efficient clinical trials. Oncology (Huntingt) 1989; 3: 439; discussion 51–3.
  • 2
    DeGeorge JJ, Ahn CH, Andrews PA, Brower ME, Giorgio DW, Goheer MA, Lee-Ham DY, McGuinn WD, Schmidt W, Sun CJ, Tripathi SC. Regulatory considerations for preclinical development of anticancer drugs. Cancer Chemother Pharmacol 1998; 41: 17385.
  • 3
    Doroshow JH, Synold TW, Gandara D, Mani S, Remick SC, Mulkerin D, Hamilton A, Sharma S, Ramanathan RK, Lenz HJ, Graham M, Longmate J, Takimoto CH, Ivy P. Pharmacology of oxaliplatin in solid tumor patients with hepatic dysfunction: a preliminary report of the National Cancer Institute Organ Dysfunction Working Group. Semin Oncol 2003; 30 (4 Suppl. 15): 149.
  • 4
    Takimoto CH, Remick SC, Sharma S, Mani S, Ramanathan RK, Doroshow J, Hamilton A, Mulkerin D, Graham M, Lockwood GF, Ivy P, Egorin M, Schuler B, Greenslade D, Goetz A, Knight R, Thomas R, Monahan BP, Dahut W, Grem JL. Dose-escalating and pharmacological study of oxaliplatin in adult cancer patients with impaired renal function: a National Cancer Institute Organ Dysfunction Working Group Study. J Clin Oncol 2003; 21: 266472.
  • 5
    Simon R, Freidlin B, Rubinstein L, Arbuck SG, Collins J, Christian MC. Accelerated titration designs for phase I clinical trials in oncology. J Natl Cancer Inst 1997; 89: 113847.
  • 6
    Collins JM, Grieshaber CK, Chabner BA. Pharmacologically guided phase I clinical trials based upon preclinical drug development. J Natl Cancer Inst 1990; 82: 13216.
  • 7
    Storer BE. Design and analysis of phase I clinical trials. Biometrics 1989; 45: 92537.
  • 8
    Piantadosi S, Liu G. Improved designs for dose escalation studies using pharmacokinetic measurements. Stat Med 1996; 15: 160518.
  • 9
    O’Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics 1990; 46: 3348.
  • 10
    Collins JM, Zaharko DS, Dedrick RL, Chabner BA. Potential roles for preclinical pharmacology in phase I clinical trials. Cancer Treat Report 1986; 70: 7380.
  • 11
    Fox E, Curt GA, Balis FM. Clinical trial design for target-based therapy. Oncologist 2002; 7: 4019.
  • 12
    Stadler WM, Ratain MJ. Development of target-based antineoplastic agents. Invest New Drugs 2000; 18: 716.
  • 13
    Gelmon KA, Eisenhauer EA, Harris AL, Ratain MJ, Workman P. Anticancer agents targeting signaling molecules and cancer cell environment: challenges for drug development? J Natl Cancer Inst 1999; 91: 12817.
  • 14
    Collins JM. Imaging and other biomarkers in early clinical studies: one step at a time or re-engineering drug development? J Clin Oncol 2005; 23: 54179.
  • 15
    Spiro TP, Gerson SL, Liu L, Majka S, Haaga J, Hoppel CL, Ingalls ST, Pluda JM, Willson JKV. O6-Benzylguanine: a clinical trial establishing the biochemical modulatory dose in tumor tissue for alkyltransferase-directed DNA repair. Cancer Res 1999; 59: 240210.
  • 16
    Kelloff GJ, Krohn KA, Larson SM, Weissleder R, Mankoff DA, Hoffman JM, Link JM, Guyton KZ, Eckelman WC, Scher HI, O’Shaughnessy J, Cheson BD, Sigman CC, Tatum JL, Mills GQ, Sullivan DC, Woodcock J. The progress and promise of molecular imaging probes in oncologic drug development. Clin Cancer Res 2005; 11: 796785.
  • 17
    Lee L, Sharma S, Morgan B, Allegrini P, Schnell C, Brueggen J, Cozens R, Horsfield M, Guenther C, Steward WP, Drevs J, Lebwohl D, Wood J, McSheehy PM. Biomarkers for assessment of pharmacologic activity for a vascular endothelial growth factor (VEGF) receptor inhibitor, PTK787/ZK 222584 (PTK/ZK): translation of biological activity in a mouse melanoma metastasis model to phase I studies in patients with advanced colorectal cancer with liver metastases. Cancer Chemother Pharmacol 2005; 57: 111.
  • 18
    Morgan B, Thomas AL, Drevs J, Hennig J, Buchert M, Jivan A, Horsfield MA, Mross K, Ball HA, Lee L, Mietlowski W, Fuxius S, Unger C, O’Byrne K, Henry A, Cherryman GR, Laurent D, Dugan M, Marme D, Steward WP. Dynamic contrast-enhanced magnetic resonance imaging as a biomarker for the pharmacological response of PTK787/ZK 222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases, in patients with advanced colorectal cancer and liver metastases: results from two phase I studies. J Clin Oncol 2003; 21: 395564.
  • 19
    Liu G, Rugo HS, Wilding G, McShane TM, Evelhoch JL, Ng C, Jackson E, Kelcz F, Yeh BM, Lee FT Jr, Charnsangavej C, Park JW, Ashton EA, Steinfeldt HM, Pithavala YK, Reich SD, Herbst RS. Dynamic contrast-enhanced magnetic resonance imaging as a pharmacodynamic measure of response after acute dosing of AG-013736, an oral angiogenesis inhibitor, in patients with advanced solid tumors: results from a phase I study. J Clin Oncol 2005; 23: 546473.
  • 20
    Hunsberger S, Rubinstein LV, Dancey J, Korn EL. Dose escalation trial designs based on a molecularly targeted endpoint. Stat Med 2005; 24: 217181.
  • 21
    Schilsky RL. End points in cancer clinical trials and the drug approval process. Clin Cancer Res 2002; 8: 9358.
  • 22
    Millar AW, Lynch KP. Rethinking clinical trials for cytostatic drugs. Nature Rev Cancer 2003; 3: 5405.
  • 23
    Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, Van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 20516.
  • 24
    Park JO, Lee SI, Song SY, Kim K, Kim WS, Jung CW, Park YS, Im YH, Kang WK, Lee MH, Lee KS, Park K. Measuring response in solid tumors: comparison of RECIST and WHO response criteria. Jpn J Clin Oncol 2003; 33: 5337.
  • 25
    Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 2003; 21: 140411.
  • 26
    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: 7199206.
  • 27
    Rothenberg ML, Carbone DP, Johnson DH. Improving the evaluation of new cancer treatments: challenges and opportunities. Nature Rev Cancer 2003; 3: 3039.
  • 28
    Kelloff GJ, Bast RC Jr,Coffey DS, D’Amico AV, Kerbel RS, Park JW, Ruddon RW, Rustin GJ, Schilsky RL, Sigman CC, Woude GF. Biomarkers, surrogate end points, and the acceleration of drug development for cancer prevention and treatment: an update prologue. Clin Cancer Res 2004; 10: 38814.
  • 29
    Park JW, Kerbel RS, Kelloff GJ, Barrett JC, Chabner BA, Parkinson DR, Peck J, Ruddon RW, Sigman CC, Slamon DJ. Rationale for biomarkers and surrogate end points in mechanism-driven oncology drug development. Clin Cancer Res 2004; 10: 388596.
  • 30
    Dybdal N, Leiberman G, Anderson S, McCune B, Bajamonde A, Cohen RL, Mass RD, Sanders C, Press MF. Determination of HER2 gene amplification by fluorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment with trastuzumab. Breast Cancer Res Treat 2005; 93: 311.
  • 31
    Evelhoch J, Garwood M, Vigneron D, Knopp M, Sullivan D, Menkens A, Clarke L, Liu G. Expanding the use of magnetic resonance in the assessment of tumor response to therapy: workshop report. Cancer Res 2005; 65: 70414.
  • 32
    Collins JM. Functional imaging in phase i studies: decorations or decision making? J Clin Oncol 2003; 21: 28079.
  • 33
    Lynch TJ, Bell DW, Sordella R, Gurubhagavatula S, Okimoto RA, Brannigan BW, Harris PL, Haserlat SM, Supko JG, Haluska FG, Louis DN, Christiani DC, Settleman J, Haber DA. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350: 212939.
  • 34
    Dancey JE, Freidlin B. Targeting epidermal growth factor receptor – are we missing the mark? Lancet 2003; 362 (9377): 62.
  • 35
    Betensky RA, Louis DN, Cairncross JG. Influence of unrecognized molecular heterogeneity on randomized clinical trials. J Clin Oncol 2002; 20: 24959.
  • 36
    Doroshow JH. Targeting EGFR in non-small-cell lung cancer. N Engl J Med 2005; 353: 2002.
  • 37
    Rosner GL, Stadler W, Ratain MJ. Randomized discontinuation design: application to cytostatic antineoplastic agents. J Clin Oncol 2002; 20: 447884.
  • 38
    Freidlin B, Simon R. Evaluation of randomized discontinuation design. J Clin Oncol 2005; 23: 50948.
  • 39
    Blower P, De Wit R, Goodin S, Aapro M. Drug–drug interactions in oncology: why are they important and can they be minimized? Crit Rev Oncol Hematol 2005; 55: 11742.
  • 40
    Scripture CD, Sparreboom A, Figg WD. Modulation of cytochrome P450 activity: implications for cancer therapy. Lancet Oncol 2005; 6: 7809.
  • 41
    Isaacs K, Haim N. Adverse interaction between capecitabine and warfarin resulting in altered coagulation parameters and bleeding: case report and review of the literature. J Chemother 2005; 17: 33942.
  • 42
    Mathijssen RH, Verweij J, De Bruijn P, Loos WJ, Sparreboom A. Effects of St. John’s wort on irinotecan metabolism. J Natl Cancer Inst 2002; 94: 12479.
  • 43
    Beijnen JH, Schellens JH. Drug interactions in oncology. Lancet Oncol 2004; 5: 48996.
  • 44
    Rabinow BE. Nanosuspensions in drug delivery. Nat Rev Drug Discov 2004; 3: 78596.
  • 45
    Prados MD, Yung WK, Jaeckle KA, Robins HI, Mehta MP, Fine HA, Wen PY, Cloughesy TF, Chang SM, Nicholas MK, Schiff D, Greenberg HS, Junck L, Fink KL, Hess KR, Kuhn J. Phase 1 trial of irinotecan (CPT-11) in patients with recurrent malignant glioma: a North American Brain Tumor Consortium study. Neuro-Oncol 2004; 6: 4454.
  • 46
    Reardon DA, Egorin MJ, Quinn JA, Rich JN Sr, Gururangan I, Vredenburgh JJ, Desjardins A, Sathornsumetee S, Provenzale JM, Herndon JE II, Dowell JM, Badruddoja MA, McLendon RE, Lagattuta TF, Kicielinski KP, Dresemann G, Sampson JH, Friedman AH, Salvado AJ, Friedman HS. Phase II study of imatinib mesylate plus hydroxyurea in adults with recurrent glioblastoma multiforme. J Clin Oncol 2005; 23: 935968.
  • 47
    Cloughesy TF, Kuhn J, Robins HI, Abrey L, Wen P, Fink K, Lieberman FS, Mehta M, Chang S, Yung A, DeAngelis L, Schiff D, Junck L, Groves M, Paquette S, Wright J, Lamborn K, Sebti SM, Prados M. Phase I trial of tipifarnib in patients with recurrent malignant glioma taking enzyme-inducing antiepileptic drugs: a North American Brain Tumor Consortium Study. J Clin Oncol 2005; 23: 664756.
  • 48
    Wen PY, Yung WK, Lamborn KA, Dahia PL, Wang Y, Peng B, Abrey LE, Raizer J, Cloughesy TF, Fink K, Gilbert M, Chang S, Junck L, Schiff D, Lieberman F, Fine HA, Mehta M, Robins HI, DeAngelis LM, Groves MD, Puduvalli VK, Levin V, Conrad C, Maher EA, Aldape K, Hayes M, Letvak L, Egorin MJ, Capdeville R, Kaplan R, Murgo AJ, Stiles C, Prados MD. Phase I/II study of imatinib mesylate (STI571) for patients with recurrent malignant gliomas (NABTC 99–08). Neuro-Oncol 2004; 6: 385 (Abtract).
  • 49
    Ando M, Saka H, Ando Y, Minami H, Kuzuya T, Yamamoto M, Watanabe A, Sakai S, Shimokata K, Hasegawa Y. Sequence effect of docetaxel and carboplatin on toxicity, tumor response and pharmacokinetics in non-small-cell lung cancer patients: a phase I study of two sequences. Cancer Chemother Pharmacol 2005; 55: 5528.
  • 50
    Ginsburg GS, Konstance RP, Allsbrook JS, Schulman KA. Implications of pharmacogenomics for drug development and clinical practice. Arch Intern Med 2005; 165: 23316.
  • 51
    Evans WE, Relling MV. Moving towards individualized medicine with pharmacogenomics. Nature 2004; 429: 4648.
  • 52
    Lewis LD. Personalized drug therapy; the genome, the chip and the physician. Br J Clin Pharmacol 2005; 60: 14.
  • 53
    Desai AA, Innocenti F, Ratain MJ. Pharmacogenomics: road to anticancer therapeutics nirvana? Oncogene 2003; 22: 66218.
  • 54
    Ulrich CM, Robien K, McLeod HL. Cancer pharmacogenetics: polymorphisms, pathways and beyond. Nat Rev Cancer 2003; 3: 91220.
  • 55
    Ames MM, Mathiesen DA, Reid JM. Differences in N-acetylation of the experimental antitumor agent batracylin in the mouse and the rat. Invest New Drugs 1991; 9: 21925.
  • 56
    Ando M, Hasegawa Y, Ando Y. Pharmacogenetics of irinotecan. A promoter polymorphism of UGT1A1 gene and severe adverse reactions to irinotecan. Invest New Drugs 2005; 23: 53945.
  • 57
    Heinrich MC, Corless CL, Demetri GD, Blanke CD, Von Mehren M, Joensuu H, McGreevey LS, Chen C-J, Van den Abbeele AD, Druker BJ, Kiese B, Eisenberg B, Roberts PJ, Singer S, Fletcher CDM, Silberman S, Dimitrijevic S, Fletcher JA. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol 2003; 21: 43429.
  • 58
    Gorre ME, Ellwood-Yen K, Chiosis G, Rosen N, Sawyers CL. BCR-ABL point mutants isolated from patients with imatinib mesylate-resistant chronic myeloid leukemia remain sensitive to inhibitors of the BCR-ABL chaperone heat shock protein 90. Blood 2002; 100: 30414.
  • 59
    FDA. Innovation or Stagnation, Challenge and Opportunity on the critical Path to New Medical Products. 2004; cited 2005. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html (last accessed: 12 May 2006).
  • 60
    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: 107986.