A phase II trial of ZD1839 (Iressa™) 750 mg per day, an oral epidermal growth factor receptor-tyrosine kinase inhibitor, in patients with metastatic colorectal cancer

Investigational New Drugs

Volumn 23, Issue 2, 2005, Pages 165-170

  MacKenzie, Mary J ^a   Hirte, Holger W ^a   Glenwood, Goss ^b   Jean, Maroun ^b   Goel, Rakesh ^b   Major, Pierre P ^a   Miller Jr , Wilson H ^c   Panasci, Lawrence ^c   Lorimer, Ian A J ^b   Batist, Gerald ^c   Matthews, Sarah ^d   Douglas, Lynn ^e   Seymour, Lesley ^d  

^a JURAVINSKI CANCER CENTRE   (Canada)

^b OTTAWA REGIONAL CANCER CENTRE   (Canada)

^c MCGILL UNIVERSITY   (Canada)

^d Queen's Cancer Research Institute   (Canada)

^e ASTRAZENECA   (United Kingdom)

Author keywords

Biopsy; Clinical trial; Colon cancer; EGF receptor; Translational

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; GEFITINIB;

ADULT; AGED; ALOPECIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER PATIENT; CANCER RECURRENCE; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CARCINOMA; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DISEASE DURATION; DOSE CALCULATION; DRUG CYTOTOXICITY; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ERUPTION; DRUG WITHDRAWAL; DRY SKIN; DYSGUESIA; DYSPEPSIA; DYSPNEA; FATIGUE; FEMALE; HUMAN; INFECTION; INSOMNIA; INTERSTITIAL NEPHRITIS; LUNG METASTASIS; MALE; MULTICENTER STUDY; NAIL DISEASE; NAUSEA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; PYELONEPHRITIS; SAMPLE SIZE; SKIN TOXICITY; STOMATITIS; TASTE DISORDER; UREMIA; VISCERAL METASTASIS; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; COLORECTAL NEOPLASMS; FEMALE; HUMANS; MALE; MIDDLE AGED; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR; TREATMENT FAILURE;

EID: 20144366145     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10637-005-5862-9     Document Type: Article

References (24)

1. Esteve J, Kricker A, Ferlay J: Facts and figures of cancer in the European Community. IARC scientific publication, Lyon, 1993, no. 121
2. Landis SH, Murray T, Holden S: Cancer Statistics, 1999. CA Cancer J Clin 49: 8-31, 1993
3. National Cancer Institute of Canada: Canadian Cancer Statistics 2002
4. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, Maroun JA, Ackland SP, Locker PK, Pirotta N, Elfring GL, Miller LL: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343: 905-914, 2000
5. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Guia G, Awad L, Rougier P: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial. Lancet 355: 1041-1047, 2000
6. Rothenberg ML, Oza AM, Burger B, Ramanathan RK, Gupta S, Garay C: Phase III trial of bolus and infusional 5-FU/leucovorin vs. oxaliplatin vs. the combination in patients with recurrent metastatic colorectal cancer following irinotecan, bolus 5-FU, and leucovorin: Interim results. In: Proceedings of European Society for Medical Oncology, abstract 30, 2002
7. Tournigand C, Louvet C, Quinaux E, Thierry A, Lledo G, Flesch M, Ganem G, Landi B, Colin P, Denet C, Mary-Mignard D, Risse ML, Byse M, de Gramont A: FOLFIRI followed by FOLFOX versus FOLFOX followed by FOLFIRI in metastatic colorectal cancer (MCRC): Final results of a phase III study. In: Proc Am Sci Clin Oncol 20: abstract 494, 2001
8. Arteaga CL : Overview of epidermal growth factor receptor biology and its role as a therapeutic target in human neoplasia. Sem Oncol 29(5) suppl 14: 3-9, 2001
9. O'Dwyer PJ, Benson AB: Epidermal growth factor receptor-targeted therapy in colorectal cancer. Sem Oncol; 29(5) suppl 14: 10-17, 2002
10. Hirata A, Ogawa S, Kometani T, Kuwano T, Naito S, Kuwano M, Ono M: ZD 1839 (Iressa) induces anti-angiogenic effects through inhibition of epidermal growth factor receptor tyrosine kinase. Cancer Res 62: 2554-2560, 2002
11. Saltz L, Rubin M, Hochster H, Tehekmaydian NS, Waksal H, Needle M, LoBuglio A: Cetuximab (IMC-C225) plus irinotecan (CPT-11) is active in CPT-11-refractory colorectal cancer (CRC) that expresses epidermal growth factor receptor (EGFR). In: Proc Am Soc Clin Oncol 20: abstract 7, 2001
12. Saltz L, Meropol NJ, Loeher PJ, Waksal H, Needle M, Mayer RJ: Single Agent IMC-C225 (Erbitux) has activity in CPT-11-refractory colorectal cancer that expresses the epidermal growth factor receptor. In: Proc Am Soc Clin Oncol abstract 504, 2002
13. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A, Bets D, Meuser M, Harstrick A, Van Cutsem E: Cetuximab (C225) alone or in combination with irinotecan (CPT-11 ) in patients with epidermal growth factor receptor (EGFR)-positive, irinotecan-refractory metastatic colorectal cancer. In: Proc Am Soc Clin Oncol abstract 1012, 2003
14. Tewes M, Schleucher N, Dirsch O, Schmid KW, Rosen O, Arens HJ, Kovar A, Seeber S, Harstirck A, Vanhoefer U: Results of a phase I trial of the humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody EMD 72000 in patients with EGFR expressing solid tumours. In: Proc Am Soc Clin Oncol abstract 378, 2002
15. Hidalgo M, Siu LL, Nemunaitis J, Rizzo J, Hammond LA, Takimoto C, Eckhardt SG, Tolcher A, Britten CD, Denis L, Farrante K, Von Hoff DD, Silberman S, Rowinsky EK: Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies. J Clin Oncol 19: 3267-3279, 2001
16. Wakeling AE, Guy SP, Woodburn JR, Ashton SE, Curry BJ, Barker AJ, Gibson KH. ZD1839 (Iressa): An orally active inhibitor of epidermal growth factor signaling with potential for cancer therapy. Cancer Res 62: 5749-5754, 2002
17. Ranson M, Hammond LA, Ferry D, Kris M, Tullo A, Murray PI, Miller V, Averbach S, Ochs J, Morris C, Feyereislova A, Swaisland H, Rowinsky EK: ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: Results of a phase I trial. J Clin Oncol 20(9): 2240-2250, 2002
18. Baselga J, Rischin D, Ranson M, Calvert H, Raymond E, Kieback DG, Kaye SB, Gianni L, Harris A, Bjork T, Averbuch SD, Feyeresilova A, Swaisland H, Rojo F, Albanell J: Phase I safety, pharmacokinetic, and pharmacodynamic trial of ZD1839, a selective oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with five selected solid tumour types. J Clin Oncol 20: 4292-4302, 2002
19. Herbst RS, Maddox A-M, Rothenburg ML, Small EJ, Rubin EH, Baselga J, Rojo F, Hong WK, Swaisland H, Averbuch SD, Ochs J, LoRusso PM: Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small cell lung cancer and other solid tumors: Results of a phase I trial. J Clin Oncol 20(18): 3815-3825, 2002
20. Goss G, Hirte H, Miller WH, Lorimer IAJ, Stewart D, Batist G, Parolin DAE, Hanna P, Stafford S, Friedmann J, Walsh W, Matthews S, Douglas L, Seymour LK: A phase I study of oral ZD1839 given daily in patients with solid tumors: IND. 122, a study of the investigational new drug program of the National Cancer Institute of Canada Clinical Trials Group. Invest New Drugs 23(2): 147-155, 2005
21. Trotti A, Byhardt R, Stetz J, Gwede C, Corn B, Fu K, Gunderson L, McCormick B, Morrisintegral M, Rich T, Shipley W, Curran W: Common toxicity criteria: Version 2.0. An improved reference for grading the acute effects of cancer treatment: Impact on radiotherapy. Int J Radiat Oncol Biol Phys 47(1): 13-47, 2000
22. Daneshmand M, Parolin DA, Hirte HW, Major P, Goss G, Stewart D, Batist G, Miller WH Jr, Matthews S, Seymour L, Lorimer IA: A pharmacodynamic study of the epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in metastatic colorectal cancer patients. Clin Cane Res 9: 2457-2464, 2003
23. Fleming TR: One sample multiple testing procedure for phase II clinical trials. Biometrics 38: 143-152, 1982
24. Perez-Soler R: Can rash associated with HER1/EGFR inhibition be used as a marker of treatment outcome? Oncol (Huntingt) 17(11 suppl 12): 23-28, 2003