A phase II trial of gefitinib with 5-fluorouracil, leucovorin, and irinotecan in patients with colorectal cancer

British Journal of Cancer

Volumn 92, Issue 10, 2005, Pages 1846-1849

  Veronese, M L ^a   Sun, W ^a   Giantonio, B ^a   Berlin, J ^a   Shults, J ^a   Davis, L ^a   Haller, D G ^a   O'Dwyer, P J ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

Colon cancer; EGFR; Gefitinib; Irinotecan

Indexed keywords

DEXAMETHASONE; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; FLUOROURACIL; FOLINIC ACID; GEFITINIB; IRINOTECAN; SEROTONIN 3 ANTAGONIST; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DRUG DERIVATIVE; QUINAZOLINE DERIVATIVE;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER GROWTH; CANCER INHIBITION; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG INFUSION; DRUG POTENTIATION; FATIGUE; FEMALE; HUMAN; HUMAN CELL; MALE; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; PHARMACODYNAMICS; PRIORITY JOURNAL; SIGNAL TRANSDUCTION; TOXICITY; TREATMENT OUTCOME; VOMITING; ADENOCARCINOMA; CHEMICALLY INDUCED DISORDER; COLORECTAL TUMOR; DRUG INTERACTION; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; PATHOLOGY; PHASE 2 CLINICAL TRIAL;

ADENOCARCINOMA; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DEHYDRATION; DIARRHEA; DRUG INTERACTIONS; FEMALE; FLUOROURACIL; HUMANS; INFUSIONS, INTRAVENOUS; LEUCOVORIN; MALE; MIDDLE AGED; NEUTROPENIA; QUINAZOLINES; TREATMENT OUTCOME;

EID: 20344380924     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bjc.6602569     Document Type: Article

References (31)

1. Bajetta E, Di Bartolomeo M, Mariani L, Cassata A, Artale S, Frustaci S, Pinotti G, Bonetti A, Carreca I, Biasco G, Bonaglia L, Marini G, Iannelli A, Cortinovis D, Ferrario E, Beretta E, Lambiase A, Buzzoni R (2004) Randomized multicenter phase II trial of two different schedule of irinotecan combined with capecitabine as first-line treatment in metastatic colorectal carcinoma. Cancer 100: 279-287
2. Chau I, Massey A, iggins L, Botwood N, Cunningham D (2004) Phase I study of gefitinib in combination with irinotecan in patients with fluoropyrimidine refractory advanced colorectal cancer. Proc Am Soc Clin Oncol 23: 3572a
3. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Mueser M, Harstrick A, Verslype C, Chau I, Van Cutsem E (2004) Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351: 337-345
4. Dodds HM, Haaz MC, Riou JF, Robert J, Rivory LP (1998) Identification of a new metabolite of CPT-11 (irinotecan): pharmacological properties and activation to SN-38. J Pharmacol Exp Ther 286: 578-583
5. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer; a multicenter randomized trial. Lancet 355: 1041-1047
6. Fisher GA, Kuo T, Cho CD, Halsey J, Jambalos CN, Schwartz EJ, Robert RV, Advani RH, Wakalee HA (2004) A phase II study of gefitinib in combination with FOLFOX-4 (IFOX) in patients with metastatic colorectal cancer. Proc Am Soc Clin Oncol 22: 3514a
7. Fusch CS, Moore MR, Harker G, Villa L, Rinaldi D, Hecht JR (2003) Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol 21: 807-814
8. Hammond LA, Figueroa J, Schwartzberg L, Ochoa L, Hidalgo M, Olivo N, Schwartz G, Smith L, Ochs J, Rowinsky EK (2001) Feasibility and pharmacokinetic trial of ZD1839 (Iressa™), an epidermal growth factor receptor tyrosine kinase inhibitor, in combination with 5-fluorouracil and leucovorin in patients with advanced colorectal cancer. Proc Am Soc Clin Oncol 20: 544a
9. Haaz MC, Rivory L, Jantet S, Ratanasavanh D, Robert J (1997) Glucuronidation of SN-38, the active metabolite of irinotecan, by human hepatic microsomes. Pharmacol Toxicol 80: 91-96
10. Han JY, Lee DH, Kim HY, Kim EA, Lee JJ, Ju SY, Shin EH, Lee JS (2003) A phase II study of weekly irinotecan and capecitabine in patients with previously treated non-small cell lung cancer. Clin Cancer Res 9: 5509-5514
11. Iacono LC, Furman WL, Crews KR, Panetta JC, Freeman BB, Daw NC, Stewart CF (2004) Effect of gefitinib on the systemic disposition of intravenous irinotecan in pediatric patients with refractory solid tumors. Proc Am Soc Clin Oncol 23: 2011a
12. Innocenti F, Undevia SD, Iyer L, Chen PX, Das S, Kocherginsky M, Karrison T, Janisch L, Ramirez J, Rudin CM, Vokes EE, Ratain MJ (2004) Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol 22: 1382-1388
13. Jordan K, Kellner O, Kegel T, Schmoll HJ, Grothey A (2004) Phase II trial of capecitabine/irinotecan and capecitabine/oxaliplatin in advanced gastrointestinal cancers. Clin Colorectal Cancer 4: 46-50
14. Kawato Y, Aonuma M, Hirota Y, Kuga H, Sato K (1991) Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res 51: 4187-4191
15. Koizumi F, Kanzawa F, Ueda Y, Koh Y, Tsukiyama S, Taguchi F, Tamura T, Saijo N, Nishio K (2004) Synergistic interaction between the EGFR tyrosine kinase inhibitor gefitinib ('Iressa') and the DNA topoisomerase I inhibitor CPT-11 (irinotecan) in human colorectal cancer cells. Int J Cancer 108: 464-472
16. Magne N, Fischel JL, Dubreuil A, Formento P, Ciccolini J, Formento JL, Tiffon C, Renee N, Marchetti S, Etienne MC, Milano G (2003) ZD1839 (Iressa) modifies the activity of key enzymes linked to fluoropyrimidine activity: rational basis for a new combination therapy with capecitabine. Clin Cancer Res 9: 4735-4742
17. Mayer A, Takimoto M, Fritz E, Schellander G, Kofler K, Ludwig H (1993) The prognostic significance of proliferating cell nuclear antigen, epidermal growth factor receptor, and mdr gene expression in colorectal cancer. Cancer 71: 2454-2460
18. Messersmith WA, Laheru DA, Senzer NN, Donehower RC, Grouleff P, Rogers T, Kelley SK, Ramies DA, Lum BL, Hidalgo M (2004) Phase I trial of irinotecan, infusional 5-fluorouracil, and leucovorin (FOLFIRI) with erlotinib (OSI-774): early termination due to increased toxicity. Clin Cancer Res 10: 6522-6527
19. Meyerhardt JA, Kwok A, Ratain MJ, McGovren JP, Fuchs CS (2004) Relationship of baseline serum bilirubin to efficacy and toxicity of single-agent irinotecan in patients with metastatic colorectal cancer. J Clin Oncol 22: 1439-1446
20. Ozvegy-Laczka C, Hegedus T, Varady G, Ujhelly O, Schuetz JD, Varadi A, Keri G, Orfi L, Nemet K, Sarkadi B (2004) High-affinity interaction of tyrosine kinase inhibitors with the ABCG2 multidrug transporter. Mol Pharmacol 65: 1485-1495
21. Rivory LP, Robert J (1995) Identification and kinetics of a beta-glucuronide metabolite of SN-38 in human plasma after administration of the camptothecin derivative irinotecan. Cancer Chemother Pharmacol 36: 176-179
22. Rivory LP, Riou JF, Haaz MC, Sable S, Vuilhorgne M, Commercon A, Pond SM, Robert J (1996) Identification and properties of a major plasma metabolite of irinotecan (CPT-11) isolated from the plasma of patients. Cancer Res 56: 3689-3694
23. Rothenberg ML, Meropol NJ, Poplin EA, Van Cutsem E, Wadler S (2001) Mortality associated with irinotecan plus bolus fluorouracil/leucovorin: summary findings of an independent panel. J Clin Oncol 19: 3801-3807
24. Rougier P, Bugat R, Douillard JY, Culine S, Suc E, Brunet P, Becouarn Y, Ychou M, Marty M, Extra JM, Bonneterre J, Adenis A, Seitz JF, Ganem G, Namer M, Conroy T, Negrier S, Merrouche Y, Burki F, Mousseau M, Herait P, Mahjoubi M (1997) Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy. J Clin Oncol 15: 251-260
25. Saloman DS, Brandt R, Fortunato C, Normanno N (1995) Epidermal growth factor-related peptides and their receptors in human malignancies. Crit Rev Oncol/Hematol 19: 183-232
26. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL (2000) Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343: 905-914
27. Saltz LB, Meropol NJ, Loehrer PJ, Needle MN, Kopit J, Mayer RJ (2004) Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol 22: 1201-1208
28. Tewes M, Schleucher N, Achterrath W, Wilke HJ, Frings S, Seeber S, Harstrick A, Rustum YM, Vanhoefer U (2003) Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study. Ann Oncol 14: 1442-1448
29. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205-216
30. Xie R, Mathijssen RHJ, Sparreboom A, Verweij J, Karlsson MO (2002) Clinical pharmacokinetics of irinotecan and its metabolites: a population analysis. J Clin Oncol 20: 3293-3301
31. Wierdl M, Wall A, Morton CL, Sampath J, Danks MK, Schuetz JD, Potter PM (2003) Carboxylesterase-mediated sensitization of human tumor cells to CPT-11 cannot override ABCG2-mediated drug resistance. Mol Pharmacol 64: 279-288