A phase i trial of imatinib in combination with mFOLFOX6-bevacizumab in patients with advanced colorectal cancer

Cancer Chemotherapy and Pharmacology

Volumn 71, Issue 2, 2013, Pages 321-330

  Michael, M ^a   Zalcberg, J ^a   Gibbs, P ^b   Lipton, L ^b,c   Gouillou, M ^a   Jefford, M ^a   McArthur, G ^a   Copeman, M ^d   Lynch, K ^e   Tebbutt, N C ^f  

^a PETER MACCALLUM CANCER CENTRE   (Australia)

^b ROYAL MELBOURNE HOSPITAL   (Australia)

^c WESTERN HOSPITAL   (Australia)

^d Pty Ltd   (Australia)

^e Australia)   (Australia)

^f AUSTIN HEALTH   (Australia)

Author keywords

Bevacizumab; Colorectal cancer; FOLFOX; Imatinib; Platelet derived growth factor; Tumoral interstitial hypertension

Indexed keywords

BEVACIZUMAB; FLUOROURACIL; FOLINIC ACID; IMATINIB; OXALIPLATIN;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COLORECTAL CANCER; CONTINUOUS INFUSION; DIARRHEA; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; EPIPHORA; ESOPHAGITIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTROINTESTINAL HEMORRHAGE; HUMAN; HYPERTENSION; INFECTION; LUNG HEMORRHAGE; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SENSORY NEUROPATHY; STOMATITIS; TREATMENT OUTCOME;

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; COLORECTAL NEOPLASMS; FEMALE; FLUOROURACIL; HUMANS; LEUCOVORIN; MALE; MIDDLE AGED; ORGANOPLATINUM COMPOUNDS; PIPERAZINES; PYRIMIDINES;

EID: 84874118753     PISSN: 03445704     EISSN: 14320843     Source Type: Journal    
DOI: 10.1007/s00280-012-2009-5     Document Type: Article

References (45)

1. Al-Batran SE, Atmaca A, Schleyer E, Pauligk C, Hosius C, Ehninger G, Jager E (2007) Imatinib mesylate for targeting the platelet-derived growth factor beta receptor in combination with fluorouracil and leucovorin in patients with refractory pancreatic, bile duct, colorectal, or gastric cancer-a dose-escalation Phase I trial. Cancer 109:1897-1904
2. Andrae J, Gallini R, Betsholtz C (2008) Role of platelet-derived growth factors in physiology and medicine. Genes Dev 22:1276-1312
3. Barberi-Heyob M, Merlin JL, Weber B (1992) Analysis of 5-fluorouracil in plasma and urine by high-performance liquid chromatography. J Chromatogr 581:281-286
4. Bergers G, Song S, Meyer-Morse N, Bergsland E, Hanahan D (2003) Benefits of targeting both pericytes and endothelial cells in the tumor vasculature with kinase inhibitors. J Clin Invest 111:1287-1295
5. Board R, Jayson GC (2005) Platelet-derived growth factor receptor (PDGFR): a target for anticancer therapeutics. Drug Resist Updat 8:75-83
6. Buchdunger E, Zimmermann J, Mett H, Meyer T, Muller M, Druker BJ, Lydon NB (1996) Inhibition of the Abl protein-tyrosine kinase in vitro and in vivo by a 2-phenylaminopyrimidine derivative. Cancer Res 56:100-104
7. Burz C, Berindan-Neagoe I, Balacescu O, Todor N, Pelau D, Floares C, Kacso G, Tanaselia C, Ursu M, Vlase L, Leucuta SE, Cristea V, Irimie A (2010) Oxaliplatin in patients with metastatic colorectal cancer: efficacy and pharmacokinetics parameters. J BUON 15:263-269
8. Cassidy J, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Saltz L (2008) Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol 26:2006-2012
9. Delbaldo C, Chatelut E, Re M, Deroussent A, Seronie-Vivien S, Jambu A, Berthaud P, Le Cesne A, Blay JY, Vassal G (2006) Pharmacokinetic-pharmacodynamic relationships of imatinib and its main metabolite in patients with advanced gastrointestinal stromal tumors. Clin Cancer Res 12:6073-6078
10. Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H (2002) Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 347:472-480
11. Eechoute K, Fransson MN, Reyners AK, de Jong FA, Sparreboom A, van der Graaf WT, Friberg LE, Schiavon G, Wiemer EA, Verweij J, Loos WJ, Mathijssen RH, De Giorgi U (2012) A long-term prospective population pharmacokinetic study on imatinib plasma concentrations in GIST patients. Clin Cancer Res 18:5780-5787
12. Frye RF, Fitzgerald SM, Lagattuta TF, Hruska MW, Egorin MJ (2004) Effect of St John's wort on imatinib mesylate pharmacokinetics. Clin Pharmacol Ther 76:323-329
13. Hecht JR, Mitchell E, Chidiac T, Scroggin C, Hagenstad C, Spigel D, Marshall J, Cohn A, McCollum D, Stella P, Deeter R, Shahin S, Amado RG (2009) A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab compared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol 27:672-680
14. Hellstrom M, Kalen M, Lindahl P, Abramsson A, Betsholtz C (1999) Role of PDGF-B and PDGFR-beta in recruitment of vascular smooth muscle cells and pericytes during embryonic blood vessel formation in the mouse. Development 126:3047-3055
15. Hochster HS, Hart LL, Ramanathan RK, Childs BH, Hainsworth JD, Cohn AL, Wong L, Fehrenbacher L, Abubakr Y, Saif MW, Schwartzberg L, Hedrick E (2008) Safety and efficacy of oxaliplatin and fluoropyrimidine regimens with or without bevacizumab as first-line treatment of metastatic colorectal cancer: results of the TREE Study. J Clin Oncol 26:3523-3529
16. Huang CH, Williamson SK, Van Veldhuizen PJ, Hsueh CT, Allen A, Tawfik O, Wick J, Smith H, Uypeckcuat AM, Mayo M, Kelly K (2011) Potential role of platelet-derived growth factor receptor inhibition using imatinib in combination with docetaxel in the treatment of recurrent non-small cell lung cancer. J Thorac Oncol 6:372-377
17. Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F (2004) Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342
18. Jain RK (1987) Transport of molecules in the tumor interstitium: a review. Cancer Res 47:3039-3051
19. Judson I, Ma P, Peng B, Verweij J, Racine A, di Paola ED, van Glabbeke M, Dimitrijevic S, Scurr M, Dumez H, van Oosterom A (2005) Imatinib pharmacokinetics in patients with gastrointestinal stromal tumour: a retrospective population pharmacokinetic study over time. EORTC Soft Tissue and Bone Sarcoma Group. Cancer Chemother Pharmacol 55:379-386
20. Klosowska-Wardega A, Hasumi Y, Burmakin M, Ahgren A, Stuhr L, Moen I, Reed RK, Rubin K, Hellberg C, Heldin CH (2009) Combined anti-angiogenic therapy targeting PDGF and VEGF receptors lowers the interstitial fluid pressure in a murine experimental carcinoma. PLoS ONE 4:e8149
21. Larson RA, Druker BJ, Guilhot F, O'Brien SG, Riviere GJ, Krahnke T, Gathmann I, Wang Y (2008) Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study. Blood 111:4022-4028
22. le Coutre P, Kreuzer KA, Pursche S, Bonin M, Leopold T, Baskaynak G, Dorken B, Ehninger G, Ottmann O, Jenke A, Bornhauser M, Schleyer E (2004) Pharmacokinetics and cellular uptake of imatinib and its main metabolite CGP74588. Cancer Chemother Pharmacol 53:313-323
23. Leveque D, Maloisel F (2005) Clinical pharmacokinetics of imatinib mesylate. In Vivo 19:77-84
24. Lindmark G, Sundberg C, Glimelius B, Pahlman L, Rubin K, Gerdin B (1993) Stromal expression of platelet-derived growth factor beta-receptor and platelet-derived growth factor B-chain in colorectal cancer. Lab Invest 69:682-689
25. Matei D, Emerson RE, Schilder J, Menning N, Baldridge LA, Johnson CS, Breen T, McClean J, Stephens D, Whalen C, Sutton G (2008) Imatinib mesylate in combination with docetaxel for the treatment of patients with advanced, platinum-resistant ovarian cancer and primary peritoneal carcinomatosis: a Hoosier Oncology Group trial. Cancer 113:723-732
26. McArthur GA, Demetri GD, van Oosterom A, Heinrich MC, Debiec-Rychter M, Corless CL, Nikolova Z, Dimitrijevic S, Fletcher JA (2005) Molecular and clinical analysis of locally advanced dermatofibrosarcoma protuberans treated with imatinib: imatinib Target Exploration Consortium Study B2225. J Clin Oncol 23:866-873
27. Messersmith WA, Jimeno A, Jacene H, Zhao M, Kulesza P, Laheru DA, Kahn Y, Spira A, Dancey J, Iacobuzio-Donahue C, Donehower RC, Carducci M, Rudek MA, Hidalgo M (2010) Phase I trial of oxaliplatin, infusional 5-fluorouracil, and leucovorin (FOLFOX4) with erlotinib and bevacizumab in colorectal cancer. Clin Colorectal Cancer 9:297-304
28. Michael M, Gibbs P, Smith R, Godwood A, Oliver S, Tebbutt N (2009) Open-label phase I trial of vandetanib in combination with mFOLFOX6 in patients with advanced colorectal cancer. Invest New Drugs 27:253-261
29. Michael M, Vlahovic G, Khamly K, Pierce KJ, Guo F, Olszanski AJ (2010) Phase Ib study of CP-868,596, a PDGFR inhibitor, combined with docetaxel with or without axitinib, a VEGFR inhibitor. Br J Cancer 103:1554-1561
30. Ogawa Y, Kawamura T, Furuhashi M, Tsukamoto K, Shimada S (2008) Improving chemotherapeutic drug penetration in melanoma by imatinib mesylate. J Dermatol Sci 51:190-199
31. Peng B, Dutreix C, Mehring G, Hayes MJ, Ben-Am M, Seiberling M, Pokorny R, Capdeville R, Lloyd P (2004) Absolute bioavailability of imatinib (Glivec) orally versus intravenous infusion. J Clin Pharmacol 44:158-162
32. Peng B, Hayes M, Resta D, Racine-Poon A, Druker BJ, Talpaz M, Sawyers CL, Rosamilia M, Ford J, Lloyd P, Capdeville R (2004) Pharmacokinetics and pharmacodynamics of imatinib in a phase I trial with chronic myeloid leukemia patients. J Clin Oncol 22:935-942
33. Pietras K (2004) Increasing tumor uptake of anticancer drugs with imatinib. Semin Oncol 31:18-23
34. Pietras K, Ostman A, Sjoquist M, Buchdunger E, Reed RK, Heldin CH, Rubin K (2001) Inhibition of platelet-derived growth factor receptors reduces interstitial hypertension and increases transcapillary transport in tumors. Cancer Res 61:2929-2934
35. Rodt SA, Ahlen K, Berg A, Rubin K, Reed RK (1996) A novel physiological function for platelet-derived growth factor-BB in rat dermis. J Physiol 495(Pt 1):193-200
36. Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM (2010) Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol 28:1772-1779
37. Safra T, Andreopoulou E, Levinson B, Borgato L, Pothuri B, Blank S, Tiersten A, Boyd L, Curtin J, Muggia F (2010) Weekly paclitaxel with intermittent imatinib mesylate (Gleevec): tolerance and activity in recurrent epithelial ovarian cancer. Anticancer Res 30:3243-3247
38. Saharinen P, Alitalo K (2003) Double target for tumor mass destruction. J Clin Invest 111:1277-1280
39. Saltz LB, Clarke S, Diaz-Rubio E, Scheithauer W, Figer A, Wong R, Koski S, Lichinitser M, Yang TS, Rivera F, Couture F, Sirzen F, Cassidy J (2008) Bevacizumab in combination with oxaliplatin-based chemotherapy as first-line therapy in metastatic colorectal cancer: a randomized phase III study. J Clin Oncol 26:2013-2019
40. Saraiya B, Karantza-Wadsworth V, Stein M, Chugh R, Mehnert J, Moss R, Lin Y, Poplin E (2009) Phase I study of gemcitabine, docetaxel, and imatinib in refractory and relapsed solid tumors. J Clin Oncol 27 (suppl; abstr e13538)
41. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (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 92:205-216
42. Vlahovic G, Rabbani ZN, Herndon JE 2nd, Dewhirst MW, Vujaskovic Z (2006) Treatment with Imatinib in NSCLC is associated with decrease of phosphorylated PDGFR-beta and VEGF expression, decrease in interstitial fluid pressure and improvement of oxygenation. Br J Cancer 95:1013-1019
43. von Wichert G, Hoehler T, Schimanski C, Moehler M, Hofheinz R, Kanzler S, Hinke A, Seufferlein T, Siebler J, Hochhaus A, Arnold D, Hallek M, Hacker UT (2011) Phase I/II trial of capecitabine (Cap) and oxaliplatin (Ox) in combination with bevacizumab (Bev) and imatinib (Ima) in patients with metastatic colorectal cancer (CRC): AIO KRK 0205. J Clin Oncol 29 (suppl; abstr 3583)
44. Wang D, Huang HJ, Kazlauskas A, Cavenee WK (1999) Induction of vascular endothelial growth factor expression in endothelial cells by platelet-derived growth factor through the activation of phosphatidylinositol 3-kinase. Cancer Res 59:1464-1472
45. Yardley DA, Burris HA III, Markus T, Spigel DR, Greco FA, Mainwaring M, Waterhouse DM, Webb CD, Hainsworth JD (2009) Phase II trial of docetaxal plus imatinib mesylate in the treatment of patients with metastatic breast cancer. Clin Breast Cancer 9:237-242