A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma

Annals of Oncology

Volumn 19, Issue 1, 2008, Pages 86-91

  Duffy, A ^a   Kortmansky, J ^b   Schwartz, G K ^a   Capanu, M ^a   Puleio, S ^a   Minsky, B ^c   Saltz, L ^a   Kelsen, D P ^d   O'Reilly, E M ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b Division of Medical Oncology   (United States)

^c UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^d NONE

Author keywords

Chemoradiation; Erlotinib; Gemcitabine; Pancreas cancer; Phase I

Indexed keywords

ERLOTINIB; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; DIARRHEA; DISEASE COURSE; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; ESOPHAGOGASTRODUODENOSCOPY; FATIGUE; FEMALE; GASTROINTESTINAL HEMORRHAGE; HUMAN; INOPERABLE CANCER; LYMPHOCYTOPENIA; MALE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS ADENOCARCINOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; THROMBOCYTOPENIA;

ADENOCARCINOMA; ADULT; AGED; ANTIMETABOLITES, ANTINEOPLASTIC; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COMBINED MODALITY THERAPY; DEOXYCYTIDINE; DISEASE PROGRESSION; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEUTROPENIA; PANCREATIC NEOPLASMS; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RADIOTHERAPY, ADJUVANT; SURVIVAL ANALYSIS; THROMBOCYTOPENIA; TREATMENT OUTCOME;

EID: 37849044904     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdm441     Document Type: Article

References (32)

1. Jemal A, Siegel R, Ward E et al. Cancer statistics, 2007. CA Cancer J Clin 2007; 57: 43-66.
2. Kelly DM, Benjamin IS. Pancreatic carcinoma. Ann Oncol 1995; 6: 19-28.
3. Abrams RA. Adjuvant therapy for pancreatic adenocarcinoma: What have we learned since 1985? Int J Radiat Oncol Biol Phys 2003; 56: 3-9.
4. Heidelberger C, Griesbach L, Montag BJ et al. Studies on fluorinated pyrimidines. II. Effects on transplanted tumors. Cancer Res 1958; 18: 305-317.
5. Burris HA III, 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 1997; 15: 2403-2413.
6. Blackstock AW, Mornex F, Partensky C et al. Adjuvant gemcitabine and concurrent radiation for patients with resected pancreatic cancer: A phase II study. Br J Cancer 2006; 95: 260-265.
7. Talamonti MS, Small W Jr., Mulcahy MF et al. A multi-institutional phase II trial of preoperative full-dose gemcitabine and concurrent radiation for patients with potentially resectable pancreatic carcinoma. Ann Surg Oncol 2OG6; 13: 150-158.
8. Oya N, Shlbuya K, Sakamoto T et al. Chemoradiotherapy in patients with pancreatic carcinoma: Phase-I study with a fixed radiation dose and escalating doses of weekly gemcitabine. Pancreatology 2006; 6: 109-116.
9. Mishra G, Butler J, Ho C et al. Phase II trial of induction gemcitabine/ CPT-11 followed by a twice-weekly infusion of gemcitabine and concurrent external beam radiation for the treatment of locally advanced pancreatic cancer. Am J Clin Oncol 2005; 28: 345-350.
10. Woodburn JR. The epidermal growth factor receptor and its inhibition in cancer therapy. Pharmacol Ther 1999; 82: 241-250.
11. Bloomston M, Bhardwaj A, Ellison EC, Frankel WL. Epidermal growth factor receptor expression in pancreatic carcinoma using tissue microarray technique. Dig Surg 2006; 23: 74-79.
12. Korc M, Chandrasekar B, Yamanaka Y et al. Overexpression of the epidermal growth factor receptor in human pancreatic cancer is associated with concomitant increases in the levels of epidermal growth factor and transforming growth factor alpha. J Clin Invest 1992; 90: 1352-1360.
13. Hidalgo M. Erlotinib: Preclinical investigations. Oncology (Williston Park) 2003; 17: 11-16.
14. 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 (15): 1960-1966.
15. Shewach DS, Lawrence TS. Radiosensitization of human solid tumor cell lines with gemcitabine. Semin Oncol 1996; 23: 65-71.
16. Shewach DS, Lawroce TS, Radiosensitization oi human tumor cells by gemcitabine in vitro. Semin Oncol 1995; 22: 68-71.
17. Shewach IDS, Lawrence TS. Gemcitabine and radiosensitization in human tumor cells. Invest New Drugs 1996; 14: 257-263.
18. Blackstock AW, Bernard SA, Richards F et al. Phase I trial of twice-weekly gemcitabine and concurrent radiation in patients with advanced pancreatic cancer. J Clin Oncol 1999; 17: 2208-2212.
19. Blackstock AW, Tepper JE, Niedwiecki D et al. Cancer and leukemia group B (CALGB) 89805: Phase II chemoradiation trial using gemcitabine in patients with locoregional adenocarcinoma of the pancreas. Int J Gastrointest Cancer 2003; 34: 107-116.
20. Joensuu TK, Kiviluoto T, Karkkainen P et al. Phase I-II trial of twice-weekly gemcitabine and concomitant irradiation in patients undergoing pancreaticoduodenectomy with extended lymphadenectomy for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys 2004; 60: 444-452.
21. Magnino A, Gatti M, Massucco P et al. Phase II trial of primary radiation therapy and concurrent chemotherapy for patients with locally advanced pancreatic cancer. Oncology 2005; 68: 493-499.
22. Zhang X, Chang A. Somatic mutations of the epidermal growth factor receptor and non-small cell lung cancer. J Med Genet 2007; 44 (3): 166-172.
23. 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: 2129-2139.
24. Huang SF, Liu HP, Li LH et al. High frequency of epidermal growth factor receptor mutations with complex patterns in non-small cell lung cancers related to gefitinib responsiveness in Taiwan. Clin Cancer Res 2004; 10: 8195-8203.
25. Paez JG, Janne PA, Lee JC et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004; 304: 1497-1500.
26. Amann J, Kalyankrishna S, Massion PP et al. Aberrant epidermal growth factor receptor signaling and enhanced sensitivity to EGFR inhibitors in lung cancer. Cancer Res 2005; 65: 226-235.
27. Han SW, Kim TY, Hwang PG et al. Predictive and prognostic impact of epidermal growth factor receptor mutation in non-small-cell lung cancer patients treated with gefitinib. J Clin Oncol 2005; 23: 2493-2501.
28. Shepherd FA, Rodrigues Pereira J, Ciuleanu T et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005; 353: 123-132.
29. Tsao MS, Sakurada A, Cutz JC et al. Erlotinib in lung cancer - molecular and clinical predictors of outcome. N Engl J Med 2005; 353: 133-144.
30. Weinstein IB. Cancer. Addiction to oncogenes - the Achilles heal of cancer. Science 2002; 297: 63-64.
31. Kwak EL, Jankowski J, Thayer SP et al. Epidermal growth factor receptor kinase domain mutations in asophageal and pancreatic adenocarcinomas. Clin Cancer Res 2006; 12: 4283-4287.
32. Iannitti D, Dipetrillo T, Akerman P et al. Erlotinib and chemoradiation followed by maintenance erlotinib for locally advanced pancreatic cancer: A phase I study. Am J Clin Oncol 2005; 28: 570-575.