Erratum: A phase II open-label randomized study to assess the efficacy and safety of selumetinib (AZD6244 [ARRY-142886]) versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line gemcitabine therapy (Invest New Drugs DOI: 10.1007/s10637-011-9687-4);A phase II open-label randomized study to assess the efficacy and safety of selumetinib (AZD6244 [ARRY-142886]) versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line gemcitabine therapy

Investigational New Drugs

Volumn 30, Issue 3, 2012, Pages 1216-1223

  Bodoky, György ^a   Timcheva, Constanta ^b   Spigel, David Robert ^c   La Stella, Phillip Joseph ^d   Ciuleanu, Tudor Eliade ^e   Pover, G ^f   Tebbutt, N C ^g  

^a Szent Laszlo Hospital   (Hungary)

^b National Oncology Center Bulgaria   (Bulgaria)

^c SARAH CANNON RESEARCH INSTITUTE   (United States)

^d ST JOSEPH MERCY HOSPITAL   (United States)

^e THE ONCOLOGY INSTITUTE PROF DR ION CHIRICUTA   (Romania)

^f ASTRAZENECA   (United Kingdom)

^g Austin Heath   (Australia)

Author keywords

Clinical trial; MEK inhibitor; Pancreatic cancer; Phase II; Selumetinib

Indexed keywords

CAPECITABINE; GEMCITABINE; SELUMETINIB;

ABDOMINAL PAIN; ACNE; ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DERMATITIS; DIARRHEA; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOLLOW UP; HAND FOOT SYNDROME; HUMAN; HYPOALBUMINEMIA; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; METASTASIS; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OPEN STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PANCREAS CANCER; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMATITIS; SURVIVAL TIME; TREATMENT DURATION;

EID: 84864346162     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-011-9713-6     Document Type: Erratum

References (32)

1. Ferlay J, Autier P, Boniol M et al (2007) Estimates of the cancer incidence andmortality in Europe in 2006. Ann Oncol 18:581-592 (Pubitemid 46359643)
2. Jemal A, Siegel R, Ward E et al (2009) Cancer statistics, 2009. CA Cancer J Clin 59:225-249
3. American Cancer Society (2010) Cancer facts & figures 2009. http://www.cancer.org/acs/groups/content/@nho/documents/document/500809webpdf. pdf. Accessed October 2010
4. NCCN Practice Guidelines in OncologyTM (2010) Pancreatic adenocarcinoma (version 2.2010). Available at http://www.nccn.org/professionals/physician-gls/ f-guidelines asp. Accessed October 2010
5. Cartwright TH, Cohn A, Varkey JA et al (2002) Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer. J Clin Oncol 20:160-164 (Pubitemid 34032607)
6. Wang D, Boerner SA, Winkler JD, Lorusso PM (2007) Clinical experience of MEK inhibitors in cancer therapy Biochim Biophys Acta 1773:1248-1255 (Pubitemid 47161034)
7. Messersmith WA, Hidalgo M, Carducci M, Eckhardt SG (2006) Novel targets in solid tumors: MEK inhibitors. Clin Adv Hematol Oncol 4:831-836 (Pubitemid 44883551)
8. Almoguera C, Shibata D, Forrester K et al (1988) Most human carcinomas of the exocrine pancreas contain mutant c-K-ras genes. Cell 53:549-554
9. Smit VT, Boot AJ, Smits AM et al (1988) KRAS codon 12 mutations occur very frequently in pancreatic adenocarcinomas. Nucleic Acids Res 16:7773-7782
10. Wang JY, Wilcoxen KM, Nomoto K, Wu S (2007) Recent advances of MEK inhibitors and their clinical progress. Curr Top Med Chem 7:1364-1378 (Pubitemid 47471235)
11. Yeh TC, Marsh V, Bernat BA et al (2007) Biological characterization of ARRY-142886 (AZD6244), a potent, highly selective mitogen-activated protein kinase kinase 1/2 inhibitor. Clin Cancer Res 13:1576-1583 (Pubitemid 46450450)
12. Adjei AA, Cohen RB, Franklin W et al (2008) Phase I pharmacokinetic and pharmacodynamic study of the oral, small-molecule mitogen-activated protein kinase kinase 1/2 inhibitor AZD6244 (ARRY-142886) in patients with advanced cancers. J Clin Oncol 26:2139-2146
13. Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 92:205-216
14. Rubinstein LV, Korn EL, Freidlin B et al (2005) Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol 23:7199-7206
15. Carroll KJ (2009) Back to basics: explaining sample size in outcome trials, are statisticians doing a thoroughjob? Pharm Stat 8:333-345
16. Pelzer U, Kubica K, Stieler J et al (2008) A randomized trial in patients with gemcitabine refractory pancreatic cancer. Final results of the CONKO 003 study. J Clin Oncol 26:4508
17. Oettle H, Pelzer U, Stieler J et al (2005) Oxaliplatin/folinic acid/5-fluorouracil 24 h (OFF) plus best supportive care versus best supportive care alone (BSC) in second-line therapy of gemcitabine-refractory advanced pancreatic cancer (CONKO 003). J Clin Oncol 23:4031
18. Yi SY, Park YS, Kim HS et al (2009) Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer. Cancer Chemother Pharmacol 63:1141-1145
19. Androulakis N, Syrigos K, Polyzos A et al (2005) Oxaliplatin for pretreated patients with advanced or metastatic pancreatic cancer: a multicenter phase II study. Cancer Invest 23:9-12 (Pubitemid 40344194)
20. Oettle H, Arnold D, Esser M et al (2000) Paclitaxel as weekly second-line therapy in patients with advanced pancreatic carcino-ma. AnticancerDrugs 11:635-638
21. Boeck S, Weigang-Kohler K, Fuchs M et al (2007) Second-line chemotherapy with pemetrexed after gemcitabine failure in patients with advanced pancreatic cancer: a multicenter phase II trial. Ann Oncol 18:745-751 (Pubitemid 46523280)
22. Wolpin BM, Hezel AF, Abrams T et al (2009) Oral mTOR inhibitor everolimus in patients with gemcitabine-refractory metastatic pancreatic cancer. J Clin Oncol 27:193-198
23. Kulke MH, Blaszkowsky LS, Ryan DP et al (2007) Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol 25:4787-4792 (Pubitemid 350086482)
24. Ulrich-Pur H, Raderer M, Verena KG et al (2003) Irinotecan plus raltitrexed vs raltitrexed alone in patients with gemcitabine-pretreated advanced pancreatic adenocarcinoma. Br J Cancer 88:1180-1184 (Pubitemid 36606330)
25. Demols A, Peeters M, Polus M et al (2006) Gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced pancre-atic adenocarcinoma: a phase II study. Br J Cancer 94:481-485 (Pubitemid 43289750)
26. Xiong HQ, Varadhachary GR Blais JC et al (2008) Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second-line therapy for patients with advanced pancreatic cancer. Cancer 113:2046-2052
27. Tsavaris N, Kosmas C, Skopelitis H et al (2005) Second-line treatment with oxaliplatin, leucovorin and 5-fluorouracil in gemcitabine-pretreated advanced pancreatic cancer: a phase II study. Invest New Drugs 23:369-375 (Pubitemid 40980360)
28. Gebbia V, Maiello E, Giuliani F et al (2007) Second-line chemotherapy in advanced pancreatic carcinoma: a multicenter survey of the Gruppo Oncologico Italia Meridionale on the activity and safety of the FOLFOX4 regimen in clinical practice. Ann Oncol 18(6):vi124-vi127
29. Pelzer U, Stieler J, Roll L et al (2009) Second-line therapy in refractory pancreatic cancer. results ofaphase II study. Onkologie 32:99-102
30. Cantore M, Rabbi C, Fiorentini G et al (2004) Combined irinotecan and oxaliplatin in patients with advanced pre-treated pancreatic cancer. Oncology 67:93-97 (Pubitemid 39482675)
31. Ignatiadis M, Polyzos A, Stathopoulos GP et al (2006) A multicenter phase II study of docetaxel in combination with gefitinib in gemcitabine-pretreated patients with advanced/meta-static pancreatic cancer. Oncology 71:159-163
32. Brell JM, Matin K, Evans T et al (2009) Phase II study ofdocetaxel and gefitinib as second-line therapy in gemcitabine pretreated patients with advanced pancreatic cancer. Oncology 76:270-274