Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second-line therapy for patients with advanced pancreatic cancer

Cancer

Volumn 113, Issue 8, 2008, Pages 2046-2052

  Xiong, Henry Q ^a   Varadhachary, Gauri R ^b   Blais, Joan C ^b   Hess, Kenneth R ^b   Abbruzzese, James L ^b   Wolff, Robert A ^b  

^a Center for Cancer and Blood Disorders   (United States)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Capecitabine; Oxaliplatin; Pancreatic cancer; Performance status; Xelox

Indexed keywords

CAPECITABINE; GEMCITABINE; OXALIPLATIN; WARFARIN;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DISEASE FREE SURVIVAL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG WITHDRAWAL; DYSESTHESIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERSENSITIVITY REACTION; KAPLAN MEIER METHOD; LARYNGEAL DYSESTHESIA; MALE; NAUSEA; NEUROTOXICITY; OVERALL SURVIVAL; PANCREAS CANCER; PATIENT COMPLIANCE; PERFORMANCE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RATING SCALE; SENSORY NEUROPATHY; SURVIVAL RATE; TUMOR VOLUME; VOMITING;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; MALE; MIDDLE AGED; PANCREATIC NEOPLASMS; SURVIVAL ANALYSIS;

EID: 55749103379     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.23810     Document Type: Article

References (31)

1. Burris HA, 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. 2001;15:2403-2413.
2. Berlin JD, Catalano P, Thomas JP. Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297. J Clin Oncol. 2002;20:3270-3275.
3. Oettle H, Richards D, Ramanathan RK, et al. A phase III trial of pemetrexed plus gemcitabine versus gemcitabine in patients with unresectable or metastatic pancreatic cancer. Ann Oncol. 2005;16:1639-1645.
4. 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. 2005;23:3509-3516.
5. 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.
6. Moore MJ, Goldstein D, Hamm J, et al. 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. 2007;25:1960-1966.
7. Miwa M, Ura M, Nishida M, et al. Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer. 1998;34:1274-1281.
8. Cartwright TH, Cohn A, Varkey JA. Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer. J Clin Oncol. 2002;20:160-164.
9. Herrmann R, Bodoky G, Ruhstaller T, et al. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Res. and the Central European Cooperative Oncology Group. J Clin Oncol. 2007;25:2212-2217.
10. Cunningham D, Chau I, Stocken D, et al. Phase III randomised comparison of gemcitabine (GEM) versus gemcitabine plus capecitabine (GEM-CAP) in patients with advanced pancreatic cancer. Presented at the European Conference (ECCO), Paris, France, October 30-November 3, 2005.
11. Faivre S, Raymond E, Woynarowski JM, et al. Supraadditive effect of 2′,2′-difluorodeoxycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol. 1999;44:117-123.
12. Diaz-Rubio E, Evans TR, Tabernero J, et al. Capecitabine (Xeloda) in combination with oxaliplatin: a phase I, dose-escalation study in patients with advanced or metastatic solid tumors. Ann Oncol. 2002;13:558-565.
13. Kornmann M, Kakler H, Butzer U, et al. Oxaliplatin exerts potent in vitro cytotoxicity in colorectal and pancreatic cancer cell lines and liver metastases. Anticancer Res. 2000; 20:3259-3264.
14. Poplin E, Levy DE, Berlin J, et al. Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose-rate infusion [FDR]) versus gemcitabine 1 oxaliplatin (GEMOX) in patients with advanced pancreatic cancer (E6201). ASCO Annual Meeting. J Clin Oncol. 2006;24(18S pt I):LBA4004.
15. Mitry E, Ducreux M, Ould-Kaci M, et al. Oxaliplatin combined with 5-FU in second line treatment of advanced pancreatic adenocarcinoma. Results of a phase II trial. Gastroenterol Clin Biol. 2006;30:357-363.
16. Thall PF, Simon R. A Bayesian approach to establishing sample size and monitoring criteria for phase II clinical trials. Control Clin Trials. 1994;15:463-481.
17. Oettle H, Pelzer U, Stieler J, et al. Oxaliplatin/folinic acid/5-fluorouracil [24h] (OFF) plus best supportive care versus best supportive care alone (BSC) in second-line therapy of gemcitabine-refractory advanced pancreatic cancer (CONKO 003). J Clin Oncol. 2005;23(16S). Abstract 4031.
18. Nakachi K, Furuse J, Ishii H, Suzuki E, Yoshino M. Prognostic factors in patients with gemcitabine-refractory pancreatic cancer. Jpn J Clin Oncol. 2007;37:114-120.
19. Ulrich-Pur H, Raderer M, Kornek GV, et al. Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma. Br J Cancer. 2003;88:1180-1184.
20. Milella M, Gelibter A, Di Cosimo S, et al. Pilot study of celecoxib and infusional 5-fluorouracil as second-line treatment for advanced pancreatic carcinoma. Cancer. 2004;101:133-138.
21. Cantore M, Rabbi C, Fiorentini G, et al. Combined irinotecan and oxaliplatin in patients with advanced pre-treated pancreatic cancer. Oncology. 2004;67:93-97.
22. Jacobs AD, Burris HA, Rivkin S, et al. A randomized phase III study of rubitecan (ORA) vs. best choice (BC) in 409 patients with refractory pancreatic cancer. Report from a North-American multi-center study. J Clin Oncol. 2004;22(14S). Abstract 4013.
23. Androulakis N, Syrigos K, Polyzos A, et al. Oxaliplatin for pretreated patients with advanced or metastatic pancreatic cancer: a multicenter phase II study. Cancer Invest. 2005; 23:9-12.
24. Tsavaris N, Kosmas C, Skopelitis H, et al. Second-line treatment with oxaliplatin, leucovorin and 5-fluorouracil in gemcitabine-pretreated advanced pancreatic cancer: a phase II study. Invest New Drugs. 2005;23:369-375.
25. Demols A, Peeters M, Polus M, et al. Gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced pancreatic adenocarcinoma: a phase II study. Br J Cancer. 2006;94:481-485.
26. Reni M, Pasetto L, Aprile G, et al. Raltitrexed-eloxantin salvage chemotherapy in gemcitabine-resistant metastatic pancreatic cancer. Br J Cancer. 2006;94:785-791.
27. Ignatiadis M, Polyzos A, Stathopoulos GP, et al. A multicenter phase II study of docetaxel in combination with gefitinib in gemcitabine-pretreated patients with advanced/metastatic pancreatic cancer. Oncology. 2006;71:159-163.
28. Boeck S, Weigang-Kohler K, Fuchs M, et al. Second-line chemotherapy with pemetrexed after gemcitabine failure in patients with advanced pancreatic cancer: a multicenter phase II trial. Ann Oncol. 2007;18:745-751.
29. Kulke MH, Blaszkowsky LS, Ryan DP, et al. Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol. 2007;25:4787-4792.
30. Boeck S, Heinemann V. The role of second-line chemotherapy after gemcitabine failure in patients with advanced pancreatic cancer. Future Oncol. 2008;4:41-50.
31. Schrag D, Archer L, Wang X, et al. A patterns-of-care study of post-progression treatment (Rx) among patients (pts) with advanced pancreas cancer (APC) after gemcitabine therapy on Cancer and Leukemia Group B (CALGB) study #80303. ASCO Annual Meeting Proceedings. J Clin Oncol. 2007;25(suppl pt 1):4524.