Phase II trial of ptk787/zk 222584 (vatalanib) administered orally once-daily or in two divided daily doses as second-line monotherapy in relapsed or progressing patients with stage iiib/iv non-small-cell lung cancer (nsclc)

Annals of Oncology

Volumn 23, Issue 3, 2012, Pages 678-687

  Gauler, T C ^a   Besse, B ^b   Mauguen, A ^b   Meric, J B ^c   Gounant, V ^d   Fischer, B ^e   Overbeck, T R ^f   Krissel, H ^g   Laurent, D ^g   Tiainen, M ^h   Commo, F ^b   Soria, J C ^b   Eberhardt, W E E ^a  

^a UNIVERSITY HOSPITAL ESSEN   (Germany)

^b INSTITUT GUSTAVE ROUSSY   (France)

^c PITIÉ SALPÊTRIÈRE HOSPITAL   (France)

^d HÔPITAL TENON   (France)

^e UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^f UNIVERSITY MEDICAL CENTER GÖTTINGEN   (Germany)

^g BAYER PHARMA AG   (Germany)

^h NONE

Author keywords

Antiangiogenesis; NSCLC; Second line treatment; Targeted therapy; Vatalanib; VEGFR TKI

Indexed keywords

CARBOPLATIN; CISPLATIN; VASCULOTROPIN RECEPTOR; VATALANIB;

ADULT; AGED; ANOREXIA; ARTICLE; ASTHENIA; CANCER CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CANCER RADIOTHERAPY; CANCER RELAPSE; CANCER STAGING; CANCER SURGERY; CHEMOTHERAPY INDUCED EMESIS; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVENING DOSAGE; FEMALE; HUMAN; HYPERTENSION; LUNG EMBOLISM; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MORNING DOSAGE; MULTICENTER STUDY; NAUSEA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; SIDE EFFECT; TREATMENT RESPONSE;

EID: 84857597028     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr255     Document Type: Article

References (31)

1. Jemal A, Siegel R, Ward E et al. Cancer statistics, 2009. CA Cancer J Clin 2009; 59: 225-249.
2. Hanna N, Shepherd FA, Fossella FV et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small-cell lung cancer previously treated with chemotherapy. J Clin Oncol 2004; 22: 1589-1597.
3. 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.
4. Zhan P, Wang J, Lv XJ et al. Prognostic value of vascular endothelial growth factor expression in patients with lung cancer: a systematic review with metaanalysis. J Thorac Oncol 2009; 4(9): 1094-1103.
5. Sandler A, Gray R, Perry MC et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006; 355: 2542-2550.
6. Reck M, Von Pawel J, Zatloukal P et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol 2009; 27: 1227-1234.
7. Koukourakis MI, Giatromanolaki A, O'Byrne KJ et al. Platelet-derived endothelial cell growth factor expression correlates with tumour angiogenesis and prognosis in non-small-cell lung cancer. Br J Cancer 1997; 75: 477-481.
8. O'Byrne KJ, Koukourakis MI, Giatromanolaki A et al. Vascular endothelial growth factor, platelet-derived endothelial cell growth factor and angiogenesis in nonsmall-cell lung cancer. Br J Cancer 2000; 82: 1427-1432.
9. Hess-Stumpp H, Haberey M, Thierauch KH. PTK 787/ZK 222584, a tyrosine kinase inhibitor of all known VEGF receptors, represses tumor growth with high efficacy. Chembiochem 2005; 6: 550-557.
10. Mross K, Drevs J, Muller M et al. Phase I clinical and pharmacokinetic study of PTK/ZK, a multiple VEGF receptor inhibitor, in patients with liver metastases from solid tumours. Eur J Cancer 2005; 41: 1291-1299.
11. Roboz GJ, Giles FJ, List AF et al. Phase 1 study of PTK787/ZK 222584, a small molecule tyrosine kinase receptor inhibitor, for the treatment of acute myeloid leukemia and myelodysplastic syndrome. Leukemia 2006; 20: 952-957.
12. Thomas AL, Trarbach T, Bartel C et al. A phase IB, open-label dose-escalating study of the oral angiogenesis inhibitor PTK787/ZK 222584 (PTK/ZK), in combination with FOLFOX4 chemotherapy in patients with advanced colorectal cancer. Ann Oncol 2007; 18: 782-788.
13. Joensuu H, De Braud F, Coco P et al. Phase II, open-label study of PTK787/ZK222584 for the treatment of metastatic gastrointestinal stromal tumors resistant to imatinib mesylate. Ann Oncol 2008; 19: 173-177.
14. Thomas AL, Morgan B, Horsfield MA et al. 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 2005; 23: 4162-4171.
15. 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 2003; 21: 3955-3964.
16. Socinski MA, Novello S, Brahmer JA et al. Multicenter, phase II trial of sunitinib in previously treated, advanced non-small-cell lung cancer. J Clin Oncol 2008; 26: 650-656.
17. Reck M, Kaiser R, Eschbach C et al. A phase II double-blind study to investigate efficacy and safety of two doses of the triple angiokinase inhibitor BIBF 1120 in patients with relapsed advanced non-small-cell lung cancer. Ann Oncol 2011 Jan 6 [Epub ahead of print], doi:10.1093/annonc/mdq618.
18. Schiller JH, Larson T, Ou SH et al. Efficacy and safety of axitinib in patients with advanced non-small-cell lung cancer: results from a phase II study. J Clin Oncol 2009; 27: 3836-3841.
19. Tan E, Goss GD, Salgia R et al. A phase 2 trial of linifanib treatment in non-small cell lung cancer (NSCLC) patients. Ann Oncol 2010; 21: (Abstr 416P).
20. Blumenschein GR Jr, Gatzemeier U, Fossella F et al. Phase II, multicenter, uncontrolled trial of single-agent sorafenib in patients with relapsed or refractory, advanced non-small-cell lung cancer. J Clin Oncol 2009; 27: 4274-4280.
21. Gatzemeier U, Blumenschein G, Fosella F et al. Phase II trial of single-agent sorafenib in patients with advanced non-small cell lung carcinoma. J Clin Oncol 2006; 24 (June 20 Supplement): 18S (Abstr 7002).
22. Novello S, Scagliotti GV, Rosell R et al. Phase II study of continuous daily sunitinib dosing in patients with previously treated advanced non-small cell lung cancer. Br J Cancer 2009; 101: 1543-1548.
23. Natale RB, Bodkin D, Govindan R et al. Vandetanib versus gefitinib in patients with advanced non-small-cell lung cancer: results from a two-part, double-blind, randomized phase II study. J Clin Oncol 2009; 27: 2523-2529.
24. Natale RB, Thongprasert S, Greco FA et al. Vandetanib versus erlotinib in patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior cytotoxic chemotherapy: a randomized, double-blind phase III trial (ZEST). J Clin Oncol 2009; 27: (Abstr 8009).
25. Scagliotti G, Novello S, Von Pawel J et al. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol 2010; 28: 1835-1842.
26. Gatzemeier U, Eisen T, Santoro A et al. Sorafenib (S) + gemcitabine/cisplatin (GC) vs GC alone in the first-line treatment of advanced non-small cell lung cancer (NSCLC): phase III NSCLC research Experience Utilizing Sorafenib (NEXUS) trial. Ann Oncol 2010; 21 (Suppl 8): (Abstr LBA16).
27. Sternberg CN, Davis ID, Mardiak J et al. Pazopanib in locally advanced or metastaic renal cell carcinoma: results of a randomized phase II trial. J Clin Oncol 2010; 28: 1061-1068.
28. Schiller JH, Lee JW, Hanna NH et al. A randomized discontinuation phase II study of sorafenib versus placebo in patients with non-small cell lung cancer who have failed at least two prior chemotherapy regimens: E2501. J Clin Oncol 2008; 26: (Abstr 8014).
29. Major P, Trarbach T, Lenz H et al. A meta-analysis of two randomized, doubleblind, placebo-controlled, phase III studies in patients (pts) with metastatic colorectal cancer (mCRC) receiving FOLFOX4 and PTK/ZK to determine clinical benefit on progression-free survival (PFS) in high LDH pts. J Clin Oncol 2006; 24: (Abstr 3529).
30. Dahlberg SE, Sandler AB, Brahmer JR et al. Clinical course of advanced nonsmall-cell lung cancer patients experiencing hypertension during treatment with bevacizumab in combination with carboplatin and paclitaxel on ECOG 4599. J Clin Oncol 2010; 28: 949-954.
31. Goss GD, Arnold A, Shepherd FA et al. Randomized, double-blind trial of carboplatin and paclitaxel with either daily oral cediranib or placebo in advanced non-small-cell lung cancer: NCIC clinical trials group BR24 study. J Clin Oncol 2010; 28: 49-55.