Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: A trial of the Eastern Cooperative Oncology Group

Journal of Clinical Oncology

Volumn 27, Issue 23, 2009, Pages 3778-3785

  Poplin, Elizabeth ^a   Feng, Yang ^a   Berlin, Jordan ^a   Rothenberg, Mace L ^a   Hochster, Howard ^a   Mitchell, Edith ^a   Alberts, Steven ^a   O'Dwyer, Peter ^a   Haller, Daniel ^a   Catalano, Paul ^a   Cella, David ^a   Benson III, Al Bowen ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

GEMCITABINE; OXALIPLATIN; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIMETABOLITE; DEOXYCYTIDINE; DRUG DERIVATIVE; PLATINUM COMPLEX;

ADULT; ADVANCED CANCER; AGED; ALLERGIC REACTION; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BONE MARROW SUPPRESSION; CANCER COMBINATION CHEMOTHERAPY; CANCER LOCALIZATION; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEMOGLOBIN BLOOD LEVEL; HUMAN; INFECTION; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; OVERALL SURVIVAL; PANCREAS CARCINOMA; PERFORMANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SIDE EFFECT; SURVIVAL RATE; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT RESPONSE; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; KAPLAN MEIER METHOD; METHODOLOGY; MIDDLE AGED; MULTICENTER STUDY; PANCREAS TUMOR; TREATMENT OUTCOME; UNITED STATES;

ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; KAPLAN-MEIERS ESTIMATE; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; PANCREATIC NEOPLASMS; TREATMENT OUTCOME; UNITED STATES;

EID: 68949114505     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.20.9007     Document Type: Article

References (25)

1. American Cancer Society: Facts and Figures 2008. Atlanta, GA, American Cancer Society, 2008
2. Parkin M, Bray FJ, Ferlay J, et al: Global Cancer Statistics 2002. CA: Cancer J for Clinicians 55:74-108, 2005
3. Burris HA III, Moore MJ, Andersen J, et al: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 15:2403-2413, 1997
4. Tempero M, Plunkett W, Ruiz van Haperen V, et al: Randomized phase II comparison of dose-intense gemcitabine: Thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol 21:3402-3408, 2003
5. Louvet C, Labianca R, Hammel P, et al: Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: Results of a GERCOR and GISCAD phase III trial. J Clin Oncol 23:3509-3516, 2005
6. Therasse P, Arbuck SG, Eisenhauer EA, et al: New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92:205-216, 2000
7. Yount S, Cella D, Webster K, et al: Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: The FACT Hepatobiliary Symptom Index. J Pain Symptom Management 24:32-44 S, 2002
8. 1-deoxycytidine (gemcitabine) after deoxycytidine kinase gene transfer: Correlation with in vivo tumor response. Clin Cancer Res 7:3263-3268, 2001
9. Venook AP, Egorin MJ, Rosner GL, et al: Phase I and pharmacokinetic trial of gemcitabine in patients with hepatic or renal dysfunction: Cancer and Leukemia Group B 9565. J Clin Oncol 18:2780-2787, 2000
10. Mann HB, Whitney DR: On a test of whether one of two random variables is stochastically larger than the other. Annals of Mathematical Statistics 18:50-60, 1947
11. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. American Statistical Association 53:457-481, 1958
12. Cox DR: Regression models and life tables. Journal Royal Statistical Society B 34:187-220, 1972
13. Mantel N: Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50:163-170, 1966
14. Fisher RA: Statistical Methods for Research Workers (ed 11). New York, NY, Hafner Publishing Company, 1950, pp 107
15. Walpole RE, Meyers RH: Probability and Statistics for Engineers and Scientists (ed 2). New York, NY, MacMillian, 1978
16. Kindler HL, Niedzwiecki D, Hollis D et al: A double-blind, placebo-controlled, randomized phase III trial of gemcitabine (G) plus bevacizumab (B) versus gemcitabine plus placebo (P) in patients with advanced pancreatic cancer (PC): A preliminary analysis of Cancer and Leukemia Group B (CALGB). J Clin Oncol 25:199s, 2007 (suppl; abstr 4508)
17. Philip PA, Benedetti J, Fenoglio-Preiser C et al: Phase III study of gemcitabine (G) plus cetuximab (C) versus gemcitabine in patients (pts) with locally advanced or metastatic pancreatic adenocarcinoma (Pca): SWOG S0205 study. J Clin Oncol 25:199s, 2007 (suppl; abstr LBA4509)
18. Xiong HQ, Rosenberg A, LoBuglio A, et al: Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor, in combination with gemcitabine for advanced pancreatic cancer: A multicenter phase II trial. J Clin Oncol 22:2610-2616, 2004
19. Kindler HL, Friberg G, Singh D, et al: Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol 23:8033-8040, 2005
20. Giovannetti E, Del Tacca M, Mey V, et al: Transcription analysis of human equilibrative nucleoside transporter-1 predicts survival in pancreas cancer patients treated with gemcitabine. Cancer Res 66:3928-3935, 2006
21. Ueno H, Kiyosawa K, Kaniwa N: Pharmacogenomics of gemcitabine: Can genetics lead to tailor made therapy? Br J Cancer 97:145-151, 2007
22. Javle MM, Okazaki T, Evans DB, et al: Polymorphisms of genes involved in gemcitabine metabolism correlate with prognosis in patients receiving neoadjuvant therapy for pancreatic cancer. J Clin Oncol 26:213s, 2008 (suppl; abstr 4501)
23. Moore MJ, Goldstein D, Hamm J, et al: National Cancer Institute of Canada Clinical Trials Group: Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: A phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol 25:1960-1966, 2007
24. Jones S, Zhang X, Williams Parsons D, et al: Core signaling pathways in human pancreatic cancers revealed by global genomic analyses. Science 321:1801-1806, 2008
25. Chu GC, Kimmelman AC, Hezel AF, et al: Stromal biology of pancreatic cancer. J Cellular Biochemistry 101:887-907, 2008