Toward efficient trials in colorectal cancer: the ARCAD Clinical Trials Program.

Aimery de Gramont, Hopital Saint Antoine, Paris, France Daniel G. Haller, Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA Daniel J. Sargent, Mayo Clinic, Cancer Center Statistics, Rochester, MN Josep Tabernero, Vall d’Hebron University Hospital, Medical Oncology Service, Barcelona, Spain Alastair Matheson, Foundation ARCAD, Paris, France Richard L. Schilsky, University of Chicago, Biological Sciences Division, Chicago, IL

[1]  J. Thigpen.  Issues in Using Progression-Free Survival When Evaluating Oncology Products , 2010 .

[2]  C. Tournigand,et al.  Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[3]  Daniel J Sargent,et al.  Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[4]  R. Schilsky.  Personalizing cancer care: American Society of Clinical Oncology presidential address 2009. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[5]  N. Funel,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. , 2009, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  F.A.M. Bordonaba,et al.  Wild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer , 2009 .

[7]  P. Laurent-Puig,et al.  Lessons from Tarceva in pancreatic cancer: where are we now, and how should future trials be designed in pancreatic cancer? , 2008, Current opinion in oncology.

[8]  G. Gasparini,et al.  Anti-VEGF therapy: the search for clinical biomarkers , 2008, Expert review of molecular diagnostics.

[9]  M. Krause,et al.  Clinical biomarkers of kinase activity: examples from EGFR inhibition trials , 2008, Cancer and Metastasis Reviews.

[10]  D. Sargent,et al.  Assessing the measure of a new drug: is survival the only thing that matters? , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[11]  M. Buyse,et al.  Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[12]  C. Sawyers.  The cancer biomarker problem , 2008, Nature.

[13]  C. Altar.  The Biomarkers Consortium: On the Critical Path of Drug Discovery , 2008, Clinical pharmacology and therapeutics.

[14]  Janet Woodcock,et al.  The FDA critical path initiative and its influence on new drug development. , 2008, Annual review of medicine.

[15]  D. Sargent,et al.  Progression-free survival is a surrogate for survival in advanced colorectal cancer. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[16]  Daniel J Sargent,et al.  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. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[17]  M. Castiglione‐Gertsch,et al.  Controversies of adjuvant endocrine treatment for breast cancer and recommendations of the 2007 St Gallen conference. , 2007, The Lancet. Oncology.

[18]  T. Frebourg,et al.  Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by Cetuximab plus chemotherapy , 2007, British Journal of Cancer.

[19]  M. Christian,et al.  NCI's cancer therapy evaluation program: a commitment to treatment trials. , 2007, Cancer treatment and research.

[20]  M. Clarke.  Meta-analyses of adjuvant therapies for women with early breast cancer: the Early Breast Cancer Trialists' Collaborative Group overview. , 2006, Annals of oncology : official journal of the European Society for Medical Oncology.

[21]  S. Barni,et al.  Alternating versus continuous "FOLFIRI" in advanced colorectal cancer (ACC): A randomized "GISCAD" trial. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[22]  M. Dong.  OPTIMOX1:A Randomized Study of FOLFOX4 or FOLFOX7 with Oxaliplatin in A Stop-and-Go Fashion in Advanced Colorectal Cancer——A GERCOR Study , 2006 .

[23]  Ma Dong,et al.  Bevacizumab plus Irinotecan,Fluorouracil,and Leucovorin for Metastatic Colorectal Cancer , 2006 .

[24]  Daniel J Sargent,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. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[25]  S. Hirschfeld,et al.  FDA drug approval summaries: oxaliplatin. , 2004, The oncologist.

[26]  Daniel J Sargent,et al.  A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. , 2004, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[27]  J. Douillard,et al.  Multicenter phase III study of uracil/tegafur and oral leucovorin versus fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. , 2002, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[28]  A. Oza,et al.  Randomized comparative study of tegafur/uracil and oral leucovorin versus parenteral fluorouracil and leucovorin in patients with previously untreated metastatic colorectal cancer. , 2002, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[29]  R. Schilsky.  End points in cancer clinical trials and the drug approval process. , 2002, Clinical cancer research : an official journal of the American Association for Cancer Research.

[30]  E. Van Cutsem,et al.  Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[31]  E Harrison,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. , 2001, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[32]  L. Saltz,et al.  Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. , 2000, The New England journal of medicine.

[33]  C. Wilson,et al.  Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. , 2000, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[34]  R. James,et al.  Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial , 2000, The Lancet.

[35]  D. Kerr,et al.  Open, randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. Tomudex Colorectal Cancer Study Group. , 1998, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.