Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT01471470|
Recruitment Status : Active, not recruiting
First Posted : November 15, 2011
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Cancer||Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer|
|Actual Study Start Date :||July 2010|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab
Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)
- R0 resection rate [ Time Frame: Up to 4 weeks after surgery ]R0 resection means complete resection of tumor.
- Overall survival [ Time Frame: Up to 3 years ]Overall survival will be measured from the start of study treatment to documented death of any cause.
- Angiogenetic biomarkers [ Time Frame: Baseline and 6 weeks after treatment ]cluster of differentiation 31, microvessel density, platelet derived growth factor, vascular endothelial growth factor-A, vascular endothelial growth factor receptor-1, vascular endothelial growth factor receptor-2, Neuropilin 1 and phosphatidylinositol glycan anchor biosynthesis, class F
- Progression-free survival [ Time Frame: Up to 3 years ]Time to progression will be measured from the start of study treatment to documented tumor progression.
- Toxicity [ Time Frame: Up to 6 months ]Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471470
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Yoon-Koo Kang, MD, PhD||Asan Medical Center|