Phase II trial of erlotinib and capecitabine for patients with previously untreated metastatic colorectal cancer

Clinical Colorectal Cancer

Volumn 8, Issue 1, 2009, Pages 38-42

  Kozuch, Peter ^a,b,c   Malamud, Steve ^b,c   Wasserman, Carrie ^a,b   Homel, Peter ^b,c   Mirzoyev, Takhir ^a,b   Grossbard, Michael ^a,b,c  

^a ST LUKE S ROOSEVELT HOSPITAL CENTER   (United States)

^b Breast Programs   (United States)

^c BETH ISRAEL MEDICAL CENTER   (United States)

Author keywords

Epidermal growth factor receptor; Loperamide; Metastasectomy; Minocycline; Tyrosine kinase inhibitor

Indexed keywords

ARTIFICIAL TEAR; CAPECITABINE; CLINDAMYCIN; DIPHENHYDRAMINE; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; LOPERAMIDE; MINOCYCLINE; PREDNISONE; PROTEIN TYROSINE KINASE INHIBITOR; SULFADIAZINE SILVER; TETRACYCLINE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL PRACTICE; CLINICAL TRIAL; COLORECTAL CANCER; DEHYDRATION; DIARRHEA; DISEASE COURSE; DRUG DOSE REDUCTION; DRUG WITHDRAWAL; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERBILIRUBINEMIA; KERATITIS; MALE; METASTASIS; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; PHASE 2 CLINICAL TRIAL; PRACTICE GUIDELINE; RASH; STOMATITIS; TREATMENT FAILURE; TREATMENT RESPONSE; VOMITING;

EID: 61349113911     PISSN: 15330028     EISSN: None     Source Type: Journal    
DOI: 10.3816/CCC.2009.n.006     Document Type: Article

References (26)

1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin 2008; 58:71-96.
2. Van Halteren HK, Roumen RM, Coebergh JW, et al. The Impact of 5-FU based bolus chemotherapy on survival in patients with advanced colorectal cancer. Anticancer Res 1999; 19:3447-9.
3. Liu G, Franssen E, Fitch MI, et al. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997; 15:110-5.
4. Hoff PM, Rafat A, Batist G, 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. J Clin Oncol 2001; 19:2282-92.
5. Van Cutsem E, Twelves C, Cassidy C, et al. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol 2001; 19:4097-106.
6. Khorana AA, Ryan CK, Cox C, et al. EGFR and VEGF expression in primary colon tumors as predictors of survival in stage II and III colon cancer. Proc Am Soc Clin Oncol2002; 21:Abstract 2395.
7. Jonker DJ, O'Callaghan CJ, Karapetis CS, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007; 357:2040-8.
8. Sobrero AF, Rivera L, Steinhauer F, et al. Randomized phase 3 trial of cetuximab plus irinotecan versus irinotecan alone for metastatic colorectal cancer in 1298 patients who have failed prior oxaliplatin-based therapy: the EPIC trial. Presented at: the 98th Annual Meeting of the American Association for Cancer Research; April 2007; Los Angeles, California.
9. Erlotinib Investigator's Brochure, 6th Ed., June 25th, 2002.
10. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2000; 343:905-14.
11. Douillard JY Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000; 355:1041-7.
12. Fuchs CS, Marshall J, Barrueco J. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: updated results from the BICC-C study. J Clin Oncol 2008; 26:689-90.
13. Nordlinger B, Sorbye H, Debois M, et al. Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial. Lancet 2008, 371:1007-16.
14. Messersmith WA, Laheru DA, Senzer NN, et al. Phase I trial of irinotecan, infusional 5-fluorouracil, and leucovorin (FOLFIRI) with erlotinib (OSI-774): early termination due to increased toxicities. Clin Cancer Res 2004; 10:6522-7.
15. Meyerhardt JA, Stuart K, Fuchs C, et al. Phase II study of FOLFOX, bevacizumab and erlotinib as first-line therapy for patients with metastastic colorectal cancer. Ann Oncol 2007; 18:1185-9.
16. Meyerhardt JA, Zhu AX, Enzinger PC, et al. Phase II study of capecitabine, oxaliplatin, and erlotinib in previously treated patients with metastastic colorectal cancer. J Clin Oncol 2006; 24:1892-7.
17. Tournigand C, Lledo G, Delord J, et al. Modified (m)Folfox7/bevacizumab (B) or modified (m)Xelox/bevacizumab with or without erlotinib (E) in first- line metastatic colorectal cancer (MCRC): Results of the feasibility phase of the DREAM-OPTIMOX3 study (GERCOR). J Clin Oncol 2007; 25(18 suppl):187s (Abstract 4097).
18. Czito BG, Willett CG, Hurwitz HI, et al. Increased toxicity with gefitinib, capecitabine, and radiation therapy in pancreatic and rectal cancer: phase I trial results. Presented at: the 2006 American Society of Clinical Oncology Gastrointestinal Cancer Symposium; June 2-6, 2006; Atlanta, GA. Abstract 116.
19. Kuo K, Cho CD, Halsey J, et al. A phase II study of gefitinib, fluorouracil, leucovorin, and oxaliplatin in previously treated patients with metastatic colorectal cancer. J Clin Oncol 2005; 23:5613-9.
20. Vincent M, Kerr I, Dingle B, et al. Capecitabine compared to capecitabine + erlotinib as first-line treatment in patients with metastatic colorectal cancer: interim efficacy results from a randomized phase 2 study. J Clin Oncol 2007; 25(18 suppl):630s (Abstract 14560).
21. Keilholz U. Erlotinib as 2nd and 3rd line therapy in patients with metastatic colorectal cancer. Results of a multicenter two cohort phase II trial. J Clin Oncol 2005; 23(16 suppl):264s (Abstract 3575).
22. Townsley CA, Major P, Siu LL, et al. Phase II study of erlotinib (OSI-774) in patients with metastatic colorectal cancer. Br J Cancer 2006; 94:1136-43.
23. Clinicaltrials.gov [Web site]. Erlotinib and cetuximab in treating patients with advanced gastrointestinal cancer, head and neck cancer, non-small cell Lung cancer, or colorectal cancer. Available at: http://clinicaltrials.gov/ ct2/show/NCT00397384. Accessed: April 2008.
24. Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350:2129.
25. Lièvre A, Bachet JB, Le Corre D, et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 2006; 66:3992-5.
26. Van Cutsem E, Lang I, D'haens G, et al. KRAS status and efficacy in the first-line treatment of patients with metastatic colorectal cancer (mCRC) treated with FOLFIRI with or without cetuximab: The CRYSTAL experience. J Clin Oncol 2008: 26(15 suppl):5s (Abstract 2).