Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer

Phase 2

Completed

• Conditions: Advanced Gastric Cancer
• Interventions: Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab

• Registration Number: NCT01471470
• Lead Sponsor: Asan Medical Center

Brief Summary

The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and bevacizumab are effective in the treatment of unresectable advanced gastric cancer.

Detailed Description

In our previous phase II study of neoadjuvant docetaxel, capecitabine and cisplatin chemotherapy, patients with unresectable gastric cancer because of invasion to adjacent organs or metastasis to para-aortic lymph nodes received benefit from neoadjuvant chemotherapy. Based on these results and reports that bevacizumab enhances response rate, we planned docetaxel, capecitabine, cisplatin, and bevacizumab as neoadjuvant chemotherapy for patients with local invasion or para-aortic node metastasis alone.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-15
• Primary Completion: 2017-12
• Study Completion: 2018-07
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Histologically documented adenocarcinoma of the stomach or gastroesophageal junction.
• Invasion to adjacent organ (T4) proven by endoscopic ultrasonography (EUS) or presence of paraaortic lymph node metastasis by CT and PET(short-axis diameter > 1 cm showing hot uptake in PET scan).
• Age 18-70 years old
• ECOG performance status 0-2
• Adequate hepatic function(serum bilirubin <1.5mg/dl, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL)
• Adequate renal function(serum creatinine <1.5mg/dl)
• Adequate bone marrow function (WBC ≥4000 cell/㎕ with ANC ≥1500 cell/㎕, platelet count ≥100,000 cell/㎕)
• HER2 negative (HER2 immunohistochemistry 0 or 1+, immunohistochemistry 2+ but FISH negative)
• Informed consent

Exclusion Criteria

• Other histologic type than adenocarcinoma
• Metastasis in other sites than paraaortic lymph nodes, like in liver or peritoneum.
• Presence or history of other cancers
• History of prior chemotherapy, antiangiogenic agents, or radiation.
• Patients with definite ascites in abdomen CT scan
• Presence of not adequately controlled CNS metastasis
• Bowel obstruction
• Evidence of gastrointestinal bleeding
• Other serious illness or medical conditions including hypertension uncontrolled by medication.
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
neoadjuvant	Docetaxel, Capecitabine, Cisplatin, Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
R0 resection rate	Up to 4 weeks after surgery	R0 resection means complete resection of tumor.

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 3 years	Overall survival will be measured from the start of study treatment to documented death of any cause.
Progression-free survival	Up to 3 years	Time to progression will be measured from the start of study treatment to documented tumor progression.
Adverse Event	Up to 28 days after end of treatment	Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0
Angiogenetic biomarkers	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of