A phase i pharmacokinetic study of TSU-68 (a multiple tyrosine kinase inhibitor of VEGFR-2, FGF and PDFG) in combination with S-1 and oxaliplatin in metastatic colorectal cancer patients previously treated with chemotherapy

Investigational New Drugs

Volumn 30, Issue 4, 2012, Pages 1501-1510

  Shin, Sang Joon ^a   Jung, Minkyu ^a   Jeung, Hei Cheul ^a   Kim, Hye Ryun ^a   Rha, Sun Young ^a   Roh, Jae Kyung ^a   Chung, Hyun Cheol ^a   Ahn, Joong Bae ^a  

^a Yonsei University College of Medicine   (South Korea)

Author keywords

Colorectal Cancer; Oxaliplatin; Phase I; S 1; TSU 68

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTIDIARRHEAL AGENT; ANTIEMETIC AGENT; ASPARTATE AMINOTRANSFERASE; FIBROBLAST GROWTH FACTOR; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; ORANTINIB; OXALIPLATIN; PLACENTAL GROWTH FACTOR; VASCULOTROPIN RECEPTOR 2;

ADJUVANT THERAPY; ADULT; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CHROMATURIA; CLINICAL ARTICLE; COHORT ANALYSIS; COLORECTAL CANCER; CONSTIPATION; DIARRHEA; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG ERUPTION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FACE EDEMA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HICCUP; HUMAN; HYPERPIGMENTATION; HYPERTENSION; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; METABOLIC DISORDER; METASTASIS POTENTIAL; MICTURITION DISORDER; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; RECOMMENDED DRUG DOSE; SENSORY NEUROPATHY; SIDE EFFECT; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 84866735754     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-011-9683-8     Document Type: Article

References (22)

1. Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery- Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22(2):229-237
2. Cassidy J, Tabernero J, Twelves C, Brunet R, Butts C, Conroy T, Debraud F, Figer A, Grossmann J, Sawada N, Schoffski P, Sobrero A, Van Cutsem E, Diaz-Rubio E. (2004) XELOX. (capecitabine plus oxaliplatin): active first-line therapy for patients with metastatic colorectal cancer. J Clin Oncol 22(11):2084-2091
3. Zang DY, Lee BH, Park HC, Song HH, Kim HJ, Jung JY, Kim JH, Kim HY, Kwon JH, Hwang SW, Park SR, Park CH, Kim KO, Kim MJ, Jang KM. (2009) Phase II study with oxaliplatin and S-1 for patients with metastatic colorectal cancer. Ann Oncol 20. (5):892-896
4. Verheul HM, Voest EE, Schlingemann RO. (2004) Are tumours angiogenesis-dependent? J Pathol 202(1):5-13
5. Hubbard J, Grothey A. (2010) Antiangiogenesis agents in colorectal cancer. Curr Opin Oncol 22(4):374-380
6. Laird AD, Vajkoczy P, Shawver LK, Thurnher A, Liang C, Mohammadi M, Schlessinger J, Ullrich A, Hubbard SR, Blake RA, Fong TA, Strawn LM, Sun L, Tang C, Hawtin R, Tang F, Shenoy N, Hirth KP, McMahon G, Cherrington. (2000) SU6668 is a potent antiangiogenic and antitumor agent that induces regression of established tumors. Cancer Res 60(15):4152-4160
7. Naumova E, Ubezio P, Garofalo A, Borsotti P, Cassis L, Riccardi E, Scanziani E, Eccles SA, Bani MR, Giavazzi R. (2006) The vascular targeting property of paclitaxel is enhanced by SU6668, a receptor tyrosine kinase inhibitor, causing apoptosis of endothelial cells and inhibition of angiogenesis. Clin Cancer Res 12(6):1839-1849
8. Kanai F, Yoshida H, Tateishi R, Sato S, Kawabe T, Obi S, Kondo Y, Taniguchi M, Tagawa K, Ikeda M, Morizane C, Okusaka T, Arioka H, Shiina S, Omata M. A phase I/II trial of the oral antiangiogenic agent TSU-68 in patients with advanced hepatocellular carcinoma. Cancer Chemother Pharmacol
9. Roodhart JM, Langenberg MH, Witteveen E, Voest EE. (2008) The molecular basis of class side effects due to treatment with inhibitors of the VEGF/VEGFR pathway. Curr Clin Pharmacol 3. (2):132-143
10. Faivre S, Raymond E, Boucher E, Douillard J, Lim HY, Kim JS, Zappa M, Lanzalone S, Lin X, Deprimo S, Harmon C, Ruiz-Garcia A, Lechuga MJ, Cheng AL. (2009) Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an open-label, multicentre, phase II study. Lancet Oncol 10(8):794-800
11. Thomas AL, Trarbach T, Bartel C, Laurent D, Henry A, Poethig M, Wang J, Masson E, Steward W, Vanhoefer U, Wiedenmann B. (2007) 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 18(4):782-788
12. Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, PatelK, Kirkwood JM, Keilholz U. (2009) Results of a phase III, randomized, placebocontrolled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol 27(17):2823-2830
13. Okamoto I, Miyazaki M, Morinaga R, Kaneda H, Ueda S, Hasegawa Y, Satoh T, Kawada A, Fukuoka M, Fukino K, Tanigawa T, Nakagawa K. (2009) Phase I clinical and pharmacokinetic study of sorafenib in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer. Invest New Drugs
14. Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, Gore M, Desai AA, Patnaik A, Xiong HQ, Rowinsky E, Abbruzzese JL, Xia C, Simantov R, Schwartz B, O'Dwyer PJ. (2006) Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 24(16):2505-2512. (15):4913-4921
15. Faivre S, Delbaldo C, Vera K, Robert C, Lozahic S, Lassau N, Bello C, Deprimo S, Brega N, Massimini G, Armand JP, Scigalla P, Raymond E. (2006) Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 24(1):25-35
16. Koizumi W, Tanabe S, Saigenji K, Ohtsu A, Boku N, Nagashima F, Shirao K, Matsumura Y, Gotoh M. (2003) Phase I/II study of S-1 combined with cisplatin in patients with advanced gastric cancer. Br J Cancer 89(12):2207-2212
17. Chu QS, Hammond LA, Schwartz G, Ochoa L, Rha SY, Denis L, Molpus K, Roedig B, Letrent SP, Damle B, DeCillis AP, Rowinsky EK. (2004) Phase I and pharmacokinetic study of the oral fluoropyrimidine S-1 on a once-daily-for-28- day schedule in patients with advanced malignancies. Clin Cancer Res 10. (15):4913-4921
18. Graham MA, Lockwood GF, Greenslade D, Brienza S, Bayssas M, Gamelin E. (2000) Clinical pharmacokinetics of oxaliplatin: a critical review. Clin Cancer Res 6(4):1205-1218
19. J. R. Hecht TT, E. Jaeger, J. Hainsworth, R. Wolff, K. Lloyd, G. Bodoky, M. Borner, D. Laurent and C. Jacques. (2005) A randomized, double-blind, placebo-controlled, phase III study in patients. (Pts) with metastatic adenocarcinoma of the colon or rectum receiving first-line chemotherapy with oxaliplatin/5-fluorouracil/leucovorin and PTK787/ZK 222584 or placebo. (CONFIRM- 1) Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings 23(16S)
20. C. Koehne EB, E. Lin, E. Van Cutsem, J. Hecht, J. Douillard, M. Moore, C. Germond, D. Laurent, C. Jacques. (2006) C. Koehne, E. Bajetta, E. Lin, E. Van Cutsem, J. Hecht, J. Douillard, M. Moore, C. Germond, D. Laurent, C. Jacques Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings 24(18S)
21. Rea DW, Nortier JW, Ten Bokkel Huinink WW, Falk S, Richel DJ, Maughan T, Groenewegen G, Smit JM, Steven N, Bakker JM, Semiond D, Kerr DJ, Punt CJ. (2005) A phase I/II and pharmacokinetic study of irinotecan in combination with capecitabine as first-line therapy for advanced colorectal cancer. Ann Oncol 16(7):1123-1132
22. Ellis LM, Hicklin DJ. (2008) VEGF-targeted therapy: mechanisms of anti-tumour activity. Nat Rev Cancer 8(8):579-591