Phase II randomized, double-blind, placebo-controlled study of AMG 386 (trebananib) in combination with cisplatin and capecitabine in patients with metastatic gastro-oesophageal cancer

Annals of Oncology

Volumn 24, Issue 3, 2013, Pages 710-718

  Eatock, M M ^a   Tebbutt, N C ^b   Bampton, C L ^c   Strickland, A H ^d   Valladares Ayerbes, M ^e   Swieboda Sadlej, A ^f   Van Cutsem, E ^g   Nanayakkara, N ^h   Sun, Y N ⁱ   Zhong, Z D ⁱ   Bass, M B ⁱ   Adewoye, A H ⁱ   Bodoky, G ^j  

^a BELFAST CITY HOSPITAL   (United Kingdom)

^b NORTHERN HEALTH   (Australia)

^c Adelaide Cancer Centre   (Australia)

^d Monash Medical Centr ^*  (Australia)

^e Hospital Teresa Herrera   (Spain)

^f Public Independent Central Clinical Hospital in Warsaw   (Poland)

^g UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^h IQVIA   (United States)

ⁱ AMGEN INC   (United States)

^j Szent Laszlo Hospital   (Hungary)

more..

Author keywords

Amg 386; Angiogenesis; Angiopoietin; Metastatic gastric cancer; Peptibody; Tie2 receptor

Indexed keywords

CAPECITABINE; CISPLATIN; PLACEBO; TREBANANIB;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ARTERIAL THROMBOEMBOLISM; ARTICLE; ASTHENIA; BLEEDING; CANCER PATIENT; CONSTIPATION; CONTROLLED STUDY; DECREASED APPETITE; DEHYDRATION; DIARRHEA; DIGESTIVE SYSTEM CANCER; DIGESTIVE SYSTEM PERFORATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DYSGEUSIA; DYSPNEA; ESOPHAGEAL ADENOCARCINOMA; FATIGUE; FEMALE; FEVER; GASTROESOPHAGEAL CANCER; GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA; HAND FOOT SYNDROME; HAZARD RATIO; HUMAN; HYPOKALEMIA; HYPOMAGNESEMIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; METASTASIS; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STOMACH ADENOCARCINOMA; TINNITUS; UPPER ABDOMINAL PAIN; VENOUS THROMBOEMBOLISM; VOMITING; WEIGHT REDUCTION; WOUND HEALING IMPAIRMENT;

EID: 84874566567     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mds502     Document Type: Article

References (44)

1. Kamangar F, Dores GM, Anderson WF. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 2006; 24: 2137-2150.
2. Jemal A, Siegel R, Ward E et al.. Cancer statistics, 2009. CA Cancer J Clin 2009; 59: 225-249.
3. NCCN clinical practice guidelines in oncology: gastric cancer, v.2.2011. National Comprehensive Cancer Network; http://www.nccn.org/professionals/ physician_gls/pdf/gastric.pdf. (14 February, 2011, date last accessed).
4. Okines A, Verheij M, Allum W et al.. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010; 21(Suppl 5): v50-v54.
5. Kang YK, Kang WK, Shin DB et al.. Capecitabine/cisplatin versus 5-fluorouracil/ cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial. Ann Oncol 2009; 20: 666-673.
6. Bang YJ, Van Cutsem E, Feyereislova A et al.. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet 2010; 376: 687-697.
7. Pinto C, Di Fabio F, Barone C et al.. Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma (DOCETUX study). Br J Cancer 2009; 101: 1261-1268.
8. Shah MA, Jhawer M, Ilson DH et al.. Phase II study of modified docetaxel, cisplatin, and fluorouracil with bevacizumab in patients with metastatic gastroesophageal adenocarcinoma. J Clin Oncol 2011; 29: 868-874.
9. Kim C, Lee JL, Choi YH et al.. Phase I dose-finding study of sorafenib in combination with capecitabine and cisplatin as a first-line treatment in patients with advanced gastric cancer. Invest New Drugs 2012; 30: 306-15.
10. Okines AF, Ashley SE, Cunningham D et al.. Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for advanced esophagogastric cancer: dose-finding study for the prospective multicenter, randomized, phase II/III REAL-3 trial. J Clin Oncol 2010; 28: 3945-3950.
11. Ohtsu A, Shah MA, Van Cutsem E et al.. Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol 2011; 29: 3968-3976.
12. Herceptin®. In (trastuzumab) Full Prescribing Information. South San Francisco, CA: Genentech, Inc. 2010.
13. European Medicines Agency. Herceptin European Public Assessment Report, Summary of Product Characteristics. London: European Medicines Agency 2010; 44 p.
14. Huang H, Bhat A, Woodnutt G et al.. Targeting the ANGPT-TIE2 pathway in malignancy. Nat Rev Cancer 2010; 10: 575-585.
15. Kitadai Y. Angiogenesis and lymphangiogenesis of gastric cancer. J Oncol 2010; 2010: 468725.
16. Etoh T, Inoue H, Tanaka S et al.. Angiopoietin-2 is related to tumor angiogenesis in gastric carcinoma: possible in vivo regulation via induction of proteases. Cancer Res 2001; 61: 2145-2153.
17. Sun XD, Liu XE, Wu JM et al.. Expression and significance of angiopoietin-2 in gastric cancer. World J Gastroenterol 2004; 10: 1382-1385.
18. Zhang Z, Zhang S, Lin J et al.. Angiopoietins/Tie-2 expression and angiogenesis in stomach carcinoma. Chin German J Clin Oncol 2006; 5: 391-395.
19. Nakayama T, Yoshizaki A, Kawahara N et al.. Expression of Tie-1 and 2 receptors, and angiopoietin-1, 2 and 4 in gastric carcinoma; immunohistochemical analyses and correlation with clinicopathological factors. Histopathology 2004; 44: 232-239.
20. Moon WS, Park HS, Yu KH et al.. Expression of angiopoietin 1, 2 and their common receptor Tie2 in human gastric carcinoma: implication for angiogenesis. J Korean Med Sci 2006; 21: 272-278.
21. Wang J, Wu K, Zhang D et al.. Expressions and clinical significances of angiopoietin-1, -2 and Tie2 in human gastric cancer. Biochem Biophys Res Commun 2005; 337: 386-393.
22. Herbst RS, Hong D, Chap L et al.. Safety, pharmacokinetics, and antitumor activity of AMG 386, a selective angiopoietin inhibitor, in adult patients with advanced solid tumors. J Clin Oncol 2009; 27: 3557-3565.
23. Coxon A, Bready J, Min H et al.. Context-dependent role of angiopoietin-1 inhibition in the suppression of angiogenesis and tumor growth: implications for AMG 386, an angiopoietin-1/2-neutralizing peptibody. Mol Cancer Ther 2010; 9: 2641-2651.
24. Karlan BY, Oza AM, Richardson GE et al.. Randomized, double-blind, placebocontrolled phase II study of AMG 386 combined with weekly paclitaxel in patients with recurrent ovarian cancer. J Clin Oncol 2012; 30: 362-371.
25. Mita AC, Takimoto CH, Mita M et al.. Phase 1 study of AMG 386, a selective angiopoietin 1/2-neutralizing peptibody, in combination with chemotherapy in adults with advanced solid tumors. Clin Cancer Res 2010; 16: 3044-3056.
26. Oliner J, Min H, Leal J et al.. Suppression of angiogenesis and tumor growth by selective inhibition of angiopoietin-2. Cancer Cell 2004; 6: 507-516.
27. 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 2000; 92: 205-216.
28. Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 1982; 38: 29-41.
29. Collett D. Modelling Survival Data in Medical Research. Boca Raton, FL: Chapman and Hall/CRC Press LLC 2003.
30. Lin D, Liu P. Nonparametric sequential tests against ordered alternatives in multiple-armed clinical trials. Biometrika 1992; 79: 420-425.
31. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998; 17: 873-890.
32. Lu J-F, Rasmussen E, Karlan BY et al.. Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection. Cancer Chemother Pharmacol 2011; (Epub ahead of print).
33. Xeloda® (capecitabine). Full Prescribing Information. South San Francisco, CA: Genentech USA, Inc. 2011.
34. Biagi JJ, Oza AM, Chalchal HI et al.. A phase II study of sunitinib in patients with recurrent epithelial ovarian and primary peritoneal carcinoma: an NCIC Clinical Trials Group Study. Ann Oncol 2011; 22: 335-340.
35. Gale NW, Thurston G, Hackett SF et al.. Angiopoietin-2 is required for postnatal angiogenesis and lymphatic patterning, and only the latter role is rescued by Angiopoietin-1. Dev Cell 2002; 3: 411-423.
36. Morisada T, Oike Y, Yamada Y et al.. Angiopoietin-1 promotes LYVE-1-positive lymphatic vessel formation. Blood 2005; 105: 4649-4656.
37. Tammela T, Saaristo A, Lohela M et al.. Angiopoietin-1 promotes lymphatic sprouting and hyperplasia. Blood 2005; 105: 4642-4648.
38. Janjigian YY, Shah MA. Molecularly targeted therapies in advanced gastric cancer. Minerva Gastroenterol Dietol 2011; 57: 75-88.
39. Ding YB, Chen GY, Xia JG et al.. Association of VCAM-1 overexpression with oncogenesis, tumor angiogenesis and metastasis of gastric carcinoma. World J Gastroenterol 2003; 9: 1409-1414.
40. Chen CN, Hsieh FJ, Cheng YM et al.. The significance of placenta growth factor in angiogenesis and clinical outcome of human gastric cancer. Cancer Lett 2004; 213: 73-82.
41. Jain RK, Duda DG, Willett CG et al.. Biomarkers of response and resistance to antiangiogenic therapy. Nat Rev Clin Oncol 2009; 6: 327-338.
42. Okugawa Y, Miki C, Toiyama Y et al.. Serum soluble VCAM-1 as a valuable prognostic marker in colorectal carcinoma [abstract]. Presented at: American Society of Clinical Oncology Gastrointestinal Cancers Symposium, San Francisco, CA, 2008.
43. Pasieka Z, Kuzdak K, Czyz W et al.. Soluble intracellular adhesion molecules (sICAM-1, sVCAM-1) in peripheral blood of patients with thyroid cancer. Neoplasma 2004; 51: 34-37.
44. Silva HC, Garcao F, Coutinho EC et al.. Soluble VCAM-1 and E-selectin in breast cancer: relationship with staging and with the detection of circulating cancer cells. Neoplasma 2006; 53: 538-543.