Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: A phase II trial of the University of Chicago Phase II Consortium

Investigational New Drugs

Volumn 30, Issue 1, 2012, Pages 382-386

  Kindler, Hedy Lee ^a   Wroblewski, Kristen ^a   Wallace, James A ^a   Hall, Michael J ^a   Locker, Gershon ^b   Nattam, Sreenivasa ^c   Agamah, Edem ^d   Stadler, Walter M ^a   Vokes, Everett E ^a  

^a UNIVERSITY OF CHICAGO   (United States)

^b NORTHSHORE UNIVERSITY HEALTHSYSTEM   (United States)

^c Fort Wayne Medical Oncology   (United States)

^d Central Illinois Hematology/Oncology   (United States)

Author keywords

Gemcitabine; Pancreatic cancer; Phase II trial; Sorafenib

Indexed keywords

GEMCITABINE; SORAFENIB;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFECT; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL HEMORRHAGE; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; LEUKOPENIA; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RASH; STOMACH PERFORATION; THROMBOCYTOPENIA; THROMBOSIS; UNITED STATES;

ADENOCARCINOMA; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; CHICAGO; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; PANCREATIC NEOPLASMS; PYRIDINES; TIME FACTORS; TREATMENT OUTCOME; UNIVERSITIES;

EID: 84856547073     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-010-9526-z     Document Type: Article

References (24)

1. Jemal A, Siegel R, Ward E et al (2009) Cancer statistics 2009 CA. Cancer J Clin 59:225-249
2. Burris HA 3rd, Moore MJ, Andersen J et al (1997) Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 15:2403-13 (Pubitemid 27251144)
3. Kindler HL, Bylow K (2007) Pancreatic cancer: An update. Curr Oncol Rep 9(3):170-6 (Pubitemid 46736349)
4. Moore MJ, Goldstein D, Hamm J et al (2007) 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 25(15):1960-1966 (Pubitemid 46972777)
5. Koliopanos A, Avgerinos C, Paraskeva C et al (2009) Molecular aspects of carcinogenesis in pancreatic cancer. Hepatolbil Pancreat Dis Int 7(4):345-356
6. Campbell PM, Groehler AL, Lee KM et al (2007) K-ras promotes growth transformation and invasion of immortalized human pancreatic cancer cells by Raf and phosphatidylinosityl kinase signaling. Cancer Res 67(5):2098-2106 (Pubitemid 46424228)
7. Alavi A, Hood JD, Frausto R et al (2003) Role of raf in vascular protection from distinct apoptotic stimuli. Science 301:94096
8. Lang SA, Schachtschneider P, Moser C et al (2008) Dual targeting of Raf and VEGFR receptor 2 reduces growth and metastasis of pancreatic cancer through direct effects on tumor cells, endothelial cells, and pericytes. Mol Cancer Ther 7(11):3509-3518
9. Wilhelm SM, Adnane L, Newll P et al (2008) Preclinical overview of sorafenib, a multikinase inhibitor that targets both raf and VEGF and PDGF receptor tyrosine kinase signaling. Mol Cancer Ther 7(10):3129-3140
10. Wilhelm SM, Carter C, Tang LY et al (2004) BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 64:7099-7109 (Pubitemid 39331023)
11. Siu LL, Awada A, Takimoto CH et al (2006) Phase I trial of sorafenib and gemcitabine in advanced solid tumors with an expanded cohort in advanced pancreatic cancer. Clin Cancer Res 12(1):144-151 (Pubitemid 43166188)
12. 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 92:205-16
13. Simon R (1989) Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1-10 (Pubitemid 19099520)
14. Kaplan E, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-81
15. Brookmeyer R, Crowley J (1982) A confidence interval for the median survival time. Biometrics 38:29-41
16. Khorana AA, Fine RL (2004) Pancreatic cancer and thromboembolic disease. Lancet Oncol 5(11):655-663 (Pubitemid 40267849)
17. Elice F, Jacoub J, Rickles FR (2007) Hemostatic complications of angiogenesis inhibitors in cancer patients. Am J Hematol 83:862-870
18. Iqbal S, Lenz HJ, Yang D et al (2008) A randomized phase II study of BAY 43-9006 in combination with gemcitabine in metastatic pancreatic carcinoma: A California Cancer Consortium study (CCC-P). Proc Am Soc Clin Oncol 26:597s18
19. Kindler HL, Niedzwiecki D, Hollis D et al. (2010) Gemcitabine plus bevacizumab compared with gemcitabine plus placebo in patients with advanced pancreatic cancer: Phase III trial of the Cancer and Leukemia Group B (CALGB 80303) J Clin Oncol 28(22):3617-3622
20. Poplin E, Feng Y, Berlin J et al (2009) Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixeddose rate infusion) compared with gemcitabine (30-minute infusion) in pancreatic carcinoma E6201: A trial of the Eastern Cooperative Oncology Group. J Clin Oncol 27(34):3778-85
21. Kindler HL, Friberg G, Singh DA et al (2005) Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol 23:8033-8040 (Pubitemid 46657405)
22. Spano JP, Chodkiewicz C, Maurel J et al (2008) Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: An open-label randomised phase II study. Lancet 371(9630):2062-2064
23. Van Cutsem E, Vervenne WL, Bennouna J et al (2009) Phase III trial of bevacizumab in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. J Clin Oncol 27(13):2231-2237
24. Kindler HL, Ioka T, Richel DJ et al (2009) A double-blinded, placebo-controlled, randomised, phase III study of axitinib (AG- 013736) plus gemcitabine versus placebo in advanced pancreatic cancer patients. Eur J Cancer Suppl 7(361):6502