Phase II trial of oxaliplatin, leucovorin and fluorouracil in patients with advanced carcinoma of the esophagus

Annals of Oncology

Volumn 16, Issue 8, 2005, Pages 1320-1325

  Mauer, A M ^a,c   Kraut, E H ^b   Krauss, S A ^a   Ansari, R H ^a   Kasza, K ^a   Szeto, L ^a   Vokes, E E ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b OHIO STATE UNIVERSITY   (United States)

^c UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

Author keywords

Esophagus cancer; Fluorouracil; Leucovorin; Oxaliplatin

Indexed keywords

CREATININE; DEXAMETHASONE; FLUOROURACIL; FOLINIC ACID; GRANULOCYTE COLONY STIMULATING FACTOR; ONDANSETRON; OXALIPLATIN;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; BOLUS INJECTION; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTINUOUS INFUSION; DIARRHEA; DRUG EFFICACY; DRUG TOLERABILITY; ESOPHAGEAL ADENOCARCINOMA; ESOPHAGUS CARCINOMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; INFECTION; LARYNX DISORDER; LEUKOPENIA; MALE; METASTASIS; MOTOR NEUROPATHY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RECURRENT CANCER; RESPIRATORY TRACT DISEASE; SENSORY NEUROPATHY; SQUAMOUS CELL CARCINOMA; STOMATITIS; THROMBOCYTOPENIA; VOMITING;

EID: 23844457288     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdi249     Document Type: Article

References (36)

1. Jemal A, Murray T, Ward E et al. Cancer statistics. CA Cancer J Clin 2005; 55: 10-30.
2. Mauer AM, Weichselbaum RR. Multimodality therapy for carcinoma of the esophagus. In Posner MC, Vokes EE, Weichselbaum RR (eds): American Cancer Society Atlas. Hamilton, Ontario: BC Dekker 2002; 157-184.
3. Kelsen DP, Ginsberg R, Pajak TF et al. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med 1998; 339: 1979-1984.
4. Herskovic A, Martz K, al-Sarraf M et al. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med 1992; 326: 1593-1598.
5. Levard H, Pouliquen X, Hay J et al. M5-Fluorourracil and cisplatin as palliative treatment of advanced oesophageal squamous cell carcinoma. A multicentre randomised controlled trial. The French Associations for Surgical Research. Eur J Surg 1998; 164: 849-857.
6. Bleiberg H, Conroy T, Paillot B et al. Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer. Eur J Cancer 1997; 33: 1216-1220.
7. Extra JM, Marty M, Brienza S, Misset JL. Pharmacokinetics and safety profile of oxaliplatin. Semin Oncol 1998; 25 (Suppl 5): 13-22.
8. Misset JL, Bleiberg H, Sutherland W et al. Oxaliplatin clinical activity: A review. Crit Rev Oncol Hematol 2000; 35: 75-93.
9. Kraker AJ, Moore CW. Accumulation of cis-diamminedichloroplatinum(II) and platinum analogues by platinum-resistant murine leukemia cells in vitro. Cancer Res 1988; 48: 9-13.
10. Pendyala L, Creaven PJ. In vitro cytotoxicity, protein binding, red blood cell partitioning, and biotransformation of oxaliplatin. Cancer Res 1993; 53: 5970-5976.
11. Rixe O, Ortuzar W, Alvarez M et al. Oxaliplatin, tetraplatin, cisplatin, and carboplatin: Spectrum of activity in drug-resistant cell lines and in the cell lines of the National Cancer Institute's Anticancer Drug Screen panel. Biochem Pharmacol 1996; 52: 1855-1865.
12. Dunn TA, Schmoll HJ, Grunwald V et al. Comparative cytotoxicity of oxaliplatin and cisplatin in non-seminomatous germ cell cancer cell lines. Invest New Drugs 1997; 15: 109-114.
13. Raymond E, Chaney SG, Taamma A, Cvitkovic E. Oxaliplatin: A review of preclinical and clinical studies. Ann Oncol 1998; 9: 1053-1071.
14. Becouarn Y, Rougier P. Clinical efficacy of oxaliplatin monotherapy: phase II trials in advanced colorectal cancer. Semin Oncol 1998; 25 (Suppl 5): 23-31.
15. Diaz-Rubio E, Sastre J, Zaniboni A et al. Oxaliplatin as single agent in previously untreated colorectal carcinoma patients: A phase II multicentric study. Ann Oncol 1998; 9: 105-108.
16. Machover D, Diaz-Rubio E, de Gramont A et al. Two consecutive phase II studies of oxaliplatin (L-OHP) for treatment of patients with advanced colorectal carcinoma who were resistant to previous treatment with fluoropyrimidines. Ann Oncol 1996; 7: 95-98.
17. Monnet I, Brienza S, Hugret F et al. Phase II study of oxaliplatin in poor-prognosis non-small cell lung cancer (NSCLC). ATTIT (Association pour le Traitement des Tumeurs Intra Thoraciques). Eur J Cancer 1998; 34: 1124-1127.
18. Chollet P, Bensmaine MA, Brienza S et al. Single agent activity of oxaliplatin in heavily pretreated advanced epithelial ovarian cancer. Ann Oncol 1996; 7: 1065-1070.
19. Degardin M, Cappelaere P, Krakowski I et al. Phase II trial of oxaliplatin (L-OHP) in advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck. Eur J Cancer B Oral Oncol 1996; 32B: 278-279.
20. Louvet C, Andre T, Tigaud JM et al. Phase II study of oxaliplatin, fluorouracil, and folinic acid in locally advanced or metastatic gastric cancer patients. J Clin Oncol 2002; 20: 4543-4548.
21. Zelek L, Cottu P, Tubiana-Hulin M et al. Phase II study of oxaliplatin and fluorouracil in taxane- and anthracycline-pretreated breast cancer patients. J Clin Oncol 2002; 20: 2551-2558.
22. Levi F, Misset JL, Brienza S et al. A chronopharmacologic phase II clinical trial with 5-fluorouracil, folinic acid, and oxaliplatin using an ambulatory multichannel programmable pump. High antitumor effectiveness against metastatic colorectal cancer. Cancer 1992; 69: 893-900.
23. Levi F, Perpoint B, Garufi C et al. Oxaliplatin activity against metastatic colorectal cancer. A phase II study of 5-day continuous venous infusion at circadian rhythm modulated rate. Eur J Cancer 1993; 9: 1280-1284.
24. Levi FA, Zidani R, Vannetzel JM et al. Chronomodulated versus fixed-infusion-rate delivery of ambulatory chemotherapy with oxaliplatin, fluorouracil, and folinic acid (leucovorin) in patients with colorectal cancer metastases: A randomized multi-institutional trial. J Natl Cancer Inst 1994; 86: 1608-1617.
25. de Gramont A, Vignoud J, Tournigand C et al. Oxaliplatin with high-dose leucovorin and 5-fluorouracil 48-hour continuous infusion in pretreated metastatic colorectal cancer. Eur J Cancer 1997; 33: 214-219.
26. de Gramont A, Louvet C, Andre T et al. A review of GERCOD trials of bimonthly leucovorin plus 5-fluorouracil 48-h continuous infusion in advanced colorectal cancer: Evolution of a regimen. Groupe d'Etude et de Recherche sur les Cancers de l'Ovaire et Digestifs (GERCOD). Eur J Cancer 1998; 34: 619-626.
27. 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 2000; 18: 2938-2947.
28. Andre T, Bensmaine MA, Louvet C et al. Multicenter phase II study of bimonthly high-dose leucovorin, fluorouracil infusion, and oxaliplatin for metastatic colorectal cancer resistant to the same leucovorin and fluorouracil regimen. J Clin Oncol 1999; 17: 3560-3568.
29. Kalbfleisch JD, Prentice RL. The statistical analysis of failure time data. New York: John Wiley and Sons 1980; 14-15.
30. Brookmeyer R, Crowley JJ. A confidence interval for the medican survival time. Biometrics 1982; 38: 29-41.
31. Sorbye H, Bruserud Y, Dahl O. Oxaliplatin-induced haematological emergency with an immediate severe thrombocytopenia and haemolysis. Acta Oncol 2001; 40: 882-883.
32. Ilson DH, Ajani J, Bhalla K et al. Phase II trial of paclitaxel, fluorouracil, and cisplatin in patients with advanced carcinoma of the esophagus. J Clin Oncol 1998; 16: 1826-1834.
33. Ilson DH, Saltz L, Enzinger P et al. Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer. J Clin Oncol 1999; 17: 3270-3275.
34. Ross P, Nicolson M, Cunningham D et al. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J Clin Oncol 2002; 20: 1996-2004.
35. Clark PI. Medical research council randomised trial of surgery with or without pre-operative chemotherapy in resectable cancer of the oesophagus (MRC Upper GI Tract Cancer Group). European Society of Medical Oncology 2000; 11 (Suppl 4): Kluwer Academic Publishers, 4.
36. Khushalani NI, Leichman CG, Proulx G et al. Oxaliplatin in combination with protracted-infusion fluorouracil and radiation: Report of a clinical trial for patients with esophageal cancer. J Clin Oncol 2002; 20: 2844-2850.