Phase II trial of vatalanib in patients with advanced or metastatic pancreatic adenocarcinoma after first-line gemcitabine therapy (PCRT O4-001)

Cancer Chemotherapy and Pharmacology

Volumn 74, Issue 2, 2014, Pages 379-387

  Dragovich, T ^a,b   Laheru, D ^c   Dayyani, F ^a   Bolejack, V ^d   Smith, L ^e   Seng, J ^f   Burris, H ^g   Rosen, P ^h   Hidalgo, M ⁱ   Ritch, P ^j   Baker, A F ^b   Raghunand, N ^b   Crowley, J ^d   Von Hoff, D D ^k  

^a Banner MD Anderson Cancer Center   (United States)

^b UNIVERSITY OF ARIZONA   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d Fred Hutchinson Cancer Research Center   (United States)

^e TEXAS ONCOLOGY   (United States)

^f Virginia Piper Cancer Institute   (United States)

^g SARAH CANNON RESEARCH INSTITUTE   (United States)

^h Tower Cancer Research Foundation ^*  (United States)

ⁱ Centro Nacional de Investigaciones Oncológicas   (Spain)

^j MEDICAL COLLEGE OF WISCONSIN   (United States)

^k Virginia G Piper Cancer Center   (United States)

more..

Author keywords

Pancreatic adenocarcinoma; Second line treatment; Tyrosine kinase inhibitor; Vatalinib

Indexed keywords

ALKALINE PHOSPHATASE; ANGIOPOIETIN 2; ASPARTATE AMINOTRANSFERASE; GEMCITABINE; INTERLEUKIN 6; INTERLEUKIN 6 RECEPTOR; LACTATE DEHYDROGENASE; OSTEOPONTIN; PLATELET DERIVED GROWTH FACTOR BB; TUMOR MARKER; VASCULOTROPIN A; VASCULOTROPIN C; VASCULOTROPIN RECEPTOR; VASCULOTROPIN RECEPTOR 1; VATALANIB;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; ARTICLE; CANCER SURVIVAL; CONTRAST ENHANCEMENT; DEHYDRATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DYNAMIC CONTRAST ENHANCED MAGNETIC RESONANCE IMAGING; FATIGUE; HUMAN; HYPERTENSION; HYPERTRANSAMINASEMIA; HYPONATREMIA; LACTATE DEHYDROGENASE BLOOD LEVEL; LIVER FUNCTION TEST; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NUCLEAR MAGNETIC RESONANCE IMAGING; NUCLEAR MAGNETIC RESONANCE SCANNER; OPEN STUDY; OUTCOME ASSESSMENT; PANCREAS ADENOCARCINOMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SURVIVAL RATE; TREATMENT RESPONSE;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEOXYCYTIDINE; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PANCREATIC NEOPLASMS; PHTHALAZINES; PROGNOSIS; PYRIDINES; SURVIVAL RATE; TUMOR MARKERS, BIOLOGICAL;

EID: 84907597082     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-014-2499-4     Document Type: Article

References (36)

1. Siegel R, Naishadham D, Jemal A (2013) Cancer statistics, 2013. CA Cancer J Clin 63(1):11-30
2. Warshaw AL, Lillemoe KD, Castillo CF (2012) Pancreatic surgery for adenocarcinoma. Curr Opin Gastroenterol 28(5):488-493
3. Von Hoff DD et al (2011) Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol 29(34):4548-4554
4. Conroy T et al (2011) FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med 364(19):1817-1825
5. Campen CJ, Dragovich T, Baker AF (2011) Management strategies in pancreatic cancer. Am J Health Syst Pharm 68(7):573-584
6. Abdelrahim M et al (2010) Angiogenesis: an update and potential drug approaches (review). Int J Oncol 36(1):5-18
7. Kleeff J et al (2007) Pancreatic cancer microenvironment. Int J Cancer 121(4):699-705 (Pubitemid 47106197)
8. Whipple C, Korc M (2008) Targeting angiogenesis in pancreatic cancer: rationale and pitfalls. Langenbecks Arch Surg 393(6):901-910
9. Garcea G et al (2006) Hypoxia and angiogenesis in pancreatic cancer. ANZ J Surg 76(9):830-842 (Pubitemid 44222321)
10. Bold G et al (2000) New anilinophthalazines as potent and orally well absorbed inhibitors of the VEGF receptor tyrosine kinases useful as antagonists of tumor-driven angiogenesis. J Med Chem 43(12):2310-2323 (Pubitemid 30431929)
11. Baker CH, Solorzano CC, Fidler IJ (2002) Blockade of vascular endothelial growth factor receptor and epidermal growth factor receptor signaling for therapy of metastatic human pancreatic cancer. Cancer Res 62(7):1996-2003 (Pubitemid 34408443)
12. Solorzano CC et al (2001) Inhibition of growth and metastasis of human pancreatic cancer growing in nude mice by PTK 787/ZK222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases. Cancer Biother Radiopharm 16(5):359-370 (Pubitemid 33151113)
13. .Thomas AL et al (2005) Phase I study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of PTK787/ZK 222584 administered twice daily in patients with advanced cancer. J Clin Oncol 23(18):4162-4171 (Pubitemid 46211322)
14. Drevs J et al (2005) Soluble markers for the assessment of biological activity with PTK787/ZK 222584 (PTK/ZK), a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor in patients with advanced colorectal cancer from two phase I trials. Ann Oncol 16(4):558-565 (Pubitemid 40613321)
15. Drevs J et al (2010) A phase IA, open-label, dose-escalating study of PTK787/ZK 222584 administered orally on a continuous dosing schedule in patients with advanced cancer. Anticancer Res 30(6):2335-2339
16. Hecht JR et al (2011) Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol 29(15):1997-2003. doi:10.1200/JCO.2010.29.4496
17. Morgan B et al (2003) Dynamic contrast-enhanced magnetic resonance imaging as a biomarker for the pharmacological response of PTK787/ZK 222584, an inhibitor of the vascular endothelial growth factor receptor tyrosine kinases, in patients with advanced colorectal cancer and liver metastases: results from two phase I studies. J Clin Oncol 21(21):3955-3964 (Pubitemid 46606209)
18. Schwartz LH et al (2009) Evaluation of lymph nodes with RECIST 1.1. Eur J Cancer 45(2):261-267
19. Tofts PS (1997) Modeling tracer kinetics in dynamic Gd-DTPA MR imaging. J Magn Reson Imaging 7(1):91-101
20. Rajaraman S et al (2011) Automated registration of sequential breath-hold dynamic contrast-enhanced MR images: a comparison of three techniques. Magn Reson Imaging 29(5):668-682
21. Moore MJ 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)
22. Rahma OE et al (2013) Second-line treatment in advanced pancreatic cancer: a comprehensive analysis of published clinical trials. Ann Oncol 24(8):1972-1979
23. Hoos WA et al (2013) Pancreatic cancer clinical trials and accrual in the United States. J Clin Oncol 31(27):3432-3438
24. Pelzer U et al (2011) Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer 47(11):1676-1681
25. Saif MW (2008) New developments in the treatment of pancreatic cancer. Highlights from the "44th ASCO Annual Meeting". Chicago, IL, USA. May 30-June 3, 2008. JOP 9(4):391-397
26. Bafeta A et al (2012) Impact of single centre status on estimates of intervention effects in trials with continuous outcomes: meta-epidemiological study. BMJ 344:e813
27. Morabito A et al (2006) Tyrosine kinase inhibitors of vascular endothelial growth factor receptors in clinical trials: current status and future directions. Oncologist 11(7):753-764 (Pubitemid 44157563)
28. .Armstrong AJ, George DJ, Halabi S (2012) Serum lactate dehydrogenase predicts for overall survival benefit in patients with metastatic renal cell carcinoma treated with inhibition of mammalian target of rapamycin. J Clin Oncol 30(27):3402-3407
29. Weide B et al (2012) Serum markers lactate dehydrogenase and S100B predict independently disease outcome in melanoma patients with distant metastasis. Br J Cancer 107(3):422-428
30. .Ebrahimi B et al (2004) Cytokines in pancreatic carcinoma: correlation with phenotypic characteristics and prognosis. Cancer 101(12):2727-2736 (Pubitemid 39603180)
31. Jain RK et al (2009) Biomarkers of response and resistance to antiangiogenic therapy. Nat Rev Clin Oncol 6(6):327-338
32. Jones S et al (2008) Core signaling pathways in human pancreatic cancers revealed by global genomic analyses. Science 321(5897):1801-1806
33. Kindler HL 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
34. Van Cutsem E 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
35. Iyer G et al (2012) Genome sequencing identifies a basis for everolimus sensitivity. Science 338(6104):221
36. .Reni M et al (2013) Maintenance sunitinib or observation in metastatic pancreatic adenocarcinoma: a phase II randomised trial. Eur J Cancer 49(17):3609-3615