Phase-II study of dose attenuated schedule of irinotecan, capecitabine, and celecoxib in advanced colorectal cancer

Cancer Chemotherapy and Pharmacology

Volumn 61, Issue 2, 2008, Pages 283-289

  El Rayes, Bassel F ^a   Zalupski, Mark M ^b   Manza, Stephanie G ^a   Rusin, Barbara ^a   Ferris, Ann Marie ^a   Vaishampayan, Ulka ^a   Heilbrun, Lance K ^a   Venkatramanamoorthy, Raghu ^a   Shields, Anthony F ^a   Philip, Philip A ^a  

^a WAYNE STATE UNIVERSITY   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

Author keywords

Capecitabine; Celecoxib; Colorectal cancer; Irinotecan

Indexed keywords

CAPECITABINE; CELECOXIB; IRINOTECAN;

ADULT; ADVANCED CANCER; AGED; ANALYTIC METHOD; ANEMIA; ARTICLE; CANCER DIAGNOSIS; CANCER GROWTH; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; CONFIDENCE INTERVAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG DOSE REGIMEN; DRUG TOLERABILITY; FEMALE; HAND FOOT SYNDROME; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; THROMBOCYTOPENIA; VOMITING;

ADENOCARCINOMA; ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC AGENTS, PHYTOGENIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; CYCLOOXYGENASE 2 INHIBITORS; DEOXYCYTIDINE; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FLUOROURACIL; HUMANS; MALE; MIDDLE AGED; PYRAZOLES; SULFONAMIDES; SURVIVAL ANALYSIS; TREATMENT FAILURE;

EID: 36348984951     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-007-0472-1     Document Type: Article

References (38)

1. Jemal A et al (2006) Cancer statistics. CA Cancer J Clin 56(2):106-130
2. Grothey A, Sargent D (2005) Overall survival of patients with advanced colorectal cancer correlates with availability of fluorouracil, irinotecan, and oxaliplatin regardless of whether doublet or single-agent therapy is used first line. J Clin Oncol 23(36):9441-9442
3. Douillard JY et al (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355(9209):1041-1047
4. Saltz LB et al (2000) Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343(13):905-914
5. Kohne CH et al (2005) Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European organisation for research and treatment of cancer gastrointestinal group study 40986. J Clin Oncol 23(22):4856-4865
6. Fuchs CS, Marshall J, Mitchell E et al (2006) A randomized trial of first-line irinotecan, fluoropyrimidine combinations with or without celecoxib in metastatic colorectal cancer (BICC-C). Presented at ASCO, Atlanta, GA
7. Hoff PM et al (2001) 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 19(8):2282-2292
8. Van Cutsem E, Hoff PM, Harper P et al (2004) Oral capecitabine vs intravenours 5-fluorouracil and leucovorin: intregrated efficacy data and novel analyses from two lagre, randomized, phase III trials. Br J Cancer 90(6):1190-1197
9. Tewes M et al (2003) Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study {dagger}. Ann Oncol 14(9):1442-1448
10. Williams CS, Mann M, DuBois RN (1999) The role of cyclooxygenases in inflammation, cancer, and development. Oncolgene 18(55):7908-7916
11. Eberhart CE, Coffey RJ, Radhika A et al (1994) Up-regulation of cyclooxygenase 2 gene expression in human colorectal adenomas and adenocarcinomas. Gastroenterology 107(4):1183-1188
12. Tsujii M et al (1998) Cyclooxygenase regulates angiogenesis induced by colon cancer cells. Cell 93(5):705-716
13. Masunaga R et al (2000) Cyclooxygenase-2 expression correlates with tumor neovascularization and prognosis in human colorectal carcinoma patients. Clin Cancer Res 6(10):4064-4068
14. Bamba H et al (2000) Prostaglandins up-regulate vascular endothelial growth factor production through distinct pathways in differentiated U937 cells. Biochem Biophys Res Commun 273(2):485-491
15. Sano H, Kawahito Y, Wilder RL et al (1995) Expression of cyclooxygenase-1 and -2 in human colorectal cancer. Cancer Res 55(17):3785-3789
16. Ohd JF, Wikstro K, Sjolander A (2000) Leukotrienes induce cell-survival signaling in intestinal epithelial cells. Gastroenterology 119(4):1007-1018
17. Cao Y et al (2000) Intracellular unesterified arachidonic acid signals apoptosis. PNAS 97(21):11280-11285
18. Tsujii M, Kawano S, DuBois RN (1997) Cyclooxygenase-2 expression in human colon cancer cells increases metastatic potential. PNAS 94(7):3336-3340
19. Lin J et al (2005) Combination of cyclooxygenase-2 inhibitors and oxaliplatin increases the growth inhibition and death in human colon cancer cells. Biochem Pharmacol 70(5):658-667
20. Matsunga N, Yamanda M, Ohira M et al (2004) Combined treatment with selective cyclooxygenase-2 inhibitor and fluorinated pyrimidines for liver metastasis of colon cancer. Biochem Pharmacol 70(5):658-667
21. Steinbach G et al (2000) The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. N Engl J Med 342(26):1946-1952
22. Whelton A, Fort JG, Puma JA et al (2001) Cyclooxygenase-2-specific inhibitors and cardiorenal function: a randomized, controlled trial of celecoxib and refecoxib in older hypertensive osteoarthritis patients. AM J Ther 8(2):89-95
23. Silverstein FE et al (2000) Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 284(10):1247-1255
24. Therasse P et al (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92(3):205-216
25. CTEP (1999) Common terminology criteria for adverse events, Version 2.0. April 30 ( http://www.ctep.cancer.gov ), DCTD, NCI, NIH, DHHS
26. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Controlled Clin Trials 10(1):1-10
27. Hintze J (2004) Power and sample size (PASS) user's guide. NCSS, Kaysville, UT
28. Casella G (1987) Refining binomial confidence intervals. CA J Stat 14:113-129
29. Mehta C, Patel N (2004) StatXact 6; statistical software for exact nonparametric inference, user manual. Cytel Software Corporation, Cambridge, MA, pp 1-29
30. Lee ET, Wang J (2003) Statistical methods for survival data analysis, 3rd edn. Wiley, New York, pp 76-91
31. Tournigand C et al (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22(2):229-237
32. Colucci G et al (2005) Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the gruppo oncologico dell'italia meridionale. J Clin Oncol 23(22):4866-4875
33. Fuchs CS et al (2003) Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol 21(5):807-814
34. De Greve J, Koehne C, Hartmann J et al (2006) Capecitabine plus irinotecan versus 5-FU/FA/irinotecan ± celecoxib in first line treatment of metastatic colorectal cancer (CRC). Long-term results of the prospective multicenter EORTC phase III study 40015. Presented at ASCO, Atlanta, GA
35. Goldberg RM et al (2004) A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22(1):23-30
36. Grothey A et al (2004) Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 22(7):1209-1214
37. Grosch S et al (2001) COX-2 independent induction of cell cycle arrest and apoptosis in colon cancer cells by the selective COX-2 inhibitor celecoxib. FASEB J 15(14):2742-2744
38. Dvory-Sobol H et al (2006) Celecoxib leads to G2/M arrest by induction of p21 and down-regulation of cyclin B1 expression in a p53-independent manner. Eur J Cancer 42(3):422-426