drugset / Trial / NCT01187212
Sorafenib Trial in Advanced and/or Recurrent Gastric Adenocarcinoma: Treatment Evaluation: STARGATE
RandomizedCrossoverOpen-labelTreatment
Summary
This study investigates the efficacy and safety profiles of sorafenib in combination of capecitabine and cisplatin, one of standard chemotherapy regimens in patients with advanced gastric cancer.
Timeline
- Start
- 2010-08
- Primary completion
- 2013-11
- Completion
- 2014-08
Publications
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- Background Bang YJ, Kang WK, Kang YK, Kim HC, Jacques C, Zuber E, Daglish B, Boudraa Y, Kim WS, Heo DS, Kim NK. Docetaxel 75 mg/m(2) is active and well tolerated in patients with metastatic or recurrent gastric cancer: a phase II trial. Jpn J Clin Oncol. 2002 Jul;32(7):248-54. doi: 10.1093/jjco/hyf057.
- Background Borgstrom P, Gold DP, Hillan KJ, Ferrara N. Importance of VEGF for breast cancer angiogenesis in vivo: implications from intravital microscopy of combination treatments with an anti-VEGF neutralizing monoclonal antibody and doxorubicin. Anticancer Res. 1999 Sep-Oct;19(5B):4203-14.
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- Background Mai M, Sakata Y, Kanamaru R, Kurihara M, Suminaga M, Ota J, Hirabayashi N, Taguchi T, Furue H. [A late phase II clinical study of RP56976 (docetaxel) in patients with advanced or recurrent gastric cancer: a cooperative study group trial (group B)]. Gan To Kagaku Ryoho. 1999 Mar;26(4):487-96. Japanese.
- Background Mavroudis D, Kourousis C, Androulakis N, Kalbakis K, Agelaki S, Kakolyris S, Souglakos J, Sarra E, Vardakis N, Hatzidaki D, Sarmonis G, Georgoulias V. Frontline treatment of advanced gastric cancer with docetaxel and granulocyte colony-stimulating factor (G-CSF): a phase II trial. Am J Clin Oncol. 2000 Aug;23(4):341-4. doi: 10.1097/00000421-200008000-00005.
- Background McCarty MF, Wey J, Stoeltzing O, Liu W, Fan F, Bucana C, Mansfield PF, Ryan AJ, Ellis LM. ZD6474, a vascular endothelial growth factor receptor tyrosine kinase inhibitor with additional activity against epidermal growth factor receptor tyrosine kinase, inhibits orthotopic growth and angiogenesis of gastric cancer. Mol Cancer Ther. 2004 Sep;3(9):1041-8.
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- Background Oh SY, Kwon HC, Kim SH, Jang JS, Kim MC, Kim KH, Han JY, Kim CO, Kim SJ, Jeong JS, Kim HJ. Clinicopathologic significance of HIF-1alpha, p53, and VEGF expression and preoperative serum VEGF level in gastric cancer. BMC Cancer. 2008 May 1;8:123. doi: 10.1186/1471-2407-8-123.
- Background Otrock ZK, Makarem JA, Shamseddine AI. Vascular endothelial growth factor family of ligands and receptors: review. Blood Cells Mol Dis. 2007 May-Jun;38(3):258-68. doi: 10.1016/j.bcmd.2006.12.003. Epub 2007 Mar 6.
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- Background Ridwelski K, Gebauer T, Fahlke J, Kroning H, Kettner E, Meyer F, Eichelmann K, Lippert H. Combination chemotherapy with docetaxel and cisplatin for locally advanced and metastatic gastric cancer. Ann Oncol. 2001 Jan;12(1):47-51. doi: 10.1023/a:1008328501128.
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- Background Shah MA, Ramanathan RK, Ilson DH, Levnor A, D'Adamo D, O'Reilly E, Tse A, Trocola R, Schwartz L, Capanu M, Schwartz GK, Kelsen DP. Multicenter phase II study of irinotecan, cisplatin, and bevacizumab in patients with metastatic gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol. 2006 Nov 20;24(33):5201-6. doi: 10.1200/JCO.2006.08.0887.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 800 mg/m2 | Oral |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 80 mg/m2 | Intravenous |
| Subject | Sorafenib | Small molecule | 400 mg | Oral |