Phase I study of intravenous vascular endothelial growth factor trap, aflibercept, in patients with advanced solid tumors

Journal of Clinical Oncology

Volumn 28, Issue 2, 2010, Pages 207-214

  Lockhart, A Craig ^a   Rothenberg, Mace L ^a   Dupont, Jakob ^a   Cooper, Wendy ^a   Chevalier, Paul ^a   Sternas, Lars ^a   Buzenet, Giliane ^a   Koehler, Elizabeth ^a   Sosman, Jeffrey A ^a   Schwartz, Lawrence H ^a   Gultekin, David H ^a   Koutcher, Jason A ^a   Donnelly, Edwin F ^a   Andal, Ric ^a   Dancy, Isabelle ^a   Spriggs, David R ^a   Tew, William P ^a  

^a VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AFLIBERCEPT; VASCULOTROPIN; ANGIOGENESIS INHIBITOR; HYBRID PROTEIN; PROTEIN KINASE INHIBITOR; VASCULOTROPIN A;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; AMENORRHEA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BACKACHE; BLOOD LEVEL; BLOOD VESSEL PERMEABILITY; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DOSE RESPONSE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPHONIA; DYSPNEA; EPISTAXIS; FATIGUE; FEMALE; FEVER; HUMAN; HYPERTENSION; IMMUNOGENICITY; KIDNEY CARCINOMA; LEUKOPENIA; MALE; MAXIMUM PLASMA CONCENTRATION; NAUSEA; NONHODGKIN LYMPHOMA; NUCLEAR MAGNETIC RESONANCE IMAGING; OVARY CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; RECOMMENDED DRUG DOSE; RECTUM ULCER; SIDE EFFECT; SOLID TUMOR; THROMBOSIS; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT RESPONSE; TUMOR VASCULARIZATION; VOMITING; INTRAVENOUS DRUG ADMINISTRATION; MAXIMUM TOLERATED DOSE; METABOLISM; MIDDLE AGED; NEOPLASM;

ADULT; AGED; ANGIOGENESIS INHIBITORS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; PROTEIN KINASE INHIBITORS; RECOMBINANT FUSION PROTEINS; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 74949119167     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2009.22.9237     Document Type: Article

References (24)

1. Coultas L, Chawengsaksophak K, Rossant J: Endothelial cells and VEGF in vascular development. Nature 438:937-945, 2005
2. Senger DR, Perruzzi CA, Feder J, et al: A highly conserved vascular permeability factor secreted by a variety of human and rodent tumor cell lines. Cancer Res 46:5629-5632, 1986
3. Berkman RA, Merrill MJ, Reinhold WC, et al: Expression of the vascular permeability factor/ vascular endothelial growth factor gene in central nervous system neoplasms. J Clin Invest 91:153-159, 1993
4. Brown LF, Berse B, Jackman RW, et al: Increased expression of vascular permeability factor (vascular endothelial growth factor) and its receptors in kidney and bladder carcinomas. Am J Pathol 143:1255-1262, 1993
5. Brown LF, Berse B, Jackman RW, et al: Expression of vascular permeability factor (vascular endothelial growth factor) and its receptors in adenocarcinomas of the gastrointestinal tract. Cancer Res 53:4727-4735, 1993
6. Ferrara N: VEGF: An update on biological and therapeutic aspects. Curr Opin Biotechnol 11:617-624, 2000
7. Guidi AJ, Abu-Jawdeh G, Berse B, et al: Vascular permeability factor (vascular endothelial growth factor) expression and angiogenesis in cervical neoplasia. J Natl Cancer Inst 87:1237-1245, 1995
8. Guidi AJ, Abu-Jawdeh G, Tognazzi K, et al: Expression of vascular permeability factor (vascular endothelial growth factor) and its receptors in endometrial carcinoma. Cancer 78:454-460, 1996
9. Plate KH, Breier G, Weich HA, et al: Vascular endothelial growth factor is a potential tumour angiogenesis factor in human gliomas in vivo. Nature 359:845-848, 1992
10. Connolly DT, Heuvelman DM, Nelson R, et al: Tumor vascular permeability factor stimulates endothelial cell growth and angiogenesis. J Clin Invest 84:1470-1478, 1989
11. Ferrara N, Davis-Smyth T: The biology of vascular endothelial growth factor. Endocr Rev 18:4-25, 1997
12. Kerbel RS: Tumor angiogenesis. N Engl J Med 358:2039-2049, 2008
13. Hurwitz H, Fehrenbacher L, Novotny W, et al: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342, 2004
14. Miller K, Wang M, Gralow J, et al: Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 357:2666-2676, 2007
15. Sandler A, Gray R, Perry MC, et al: Paclitaxelcarboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355:2542-2550, 2006
16. Holash J, Davis S, Papadopoulos N, et al: VEGF-Trap: A VEGF blocker with potent antitumor effects. Proc Natl Acad Sci U S A 99:11393-11398, 2002
17. Therasse P, Arbuck SG, Eisenhauer EA, et al: 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, 2000
18. Rudge JS, Holash J, Hylton D, et al: Inaugural article: VEGF Trap complex formation measures production rates of VEGF, providing a biomarker for predicting efficacious angiogenic blockade. Proc Natl Acad Sci U S A 104:18363-18370, 2007
19. Kety SS: The theory and applications of the exchange of inert gas at the lungs and tissues. Pharmacol Rev 3:1-41, 1951
20. Tofts PS, Brix G, Buckley DL, et al: Estimating kinetic parameters from dynamic contrast-enhanced T(1)-weighted MRI of a diffusable tracer: Standardized quantities and symbols. J Magn Reson Imaging 10:223-232, 1999
21. Tofts PS, Kermode AG: Measurement of the blood-brain barrier permeability and leakage space using dynamic MR imaging. I. Fundamental concepts. Magn Reson Med 17:357-367, 1991
22. Weinmann HJ, Laniado M, Mutzel W: Pharmacokinetics of GdDTPA/dimeglumine after intravenous injection into healthy volunteers. Physiol Chem Phys Med NMR 16:167-172, 1984
23. Knopp MV, Giesel FL, Marcos H, et al: Dynamic contrast-enhanced magnetic resonance imaging in oncology. Top Magn Reson Imaging 12:301-308, 2001
24. Morgan B, Thomas AL, Drevs J, et al: 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 21:3955-3964, 2003