A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer

Asan Medical Center1 site in 1 country31 target enrollmentJuly 2010

ConditionsAdvanced Gastric Cancer

InterventionsDocetaxel, Capecitabine, Cisplatin, Bevacizumab

DrugsDocetaxel, Capecitabine, Cisplatin, Bevacizumab

Overview

Phase: Phase 2
Intervention: Docetaxel, Capecitabine, Cisplatin, Bevacizumab
Conditions: Advanced Gastric Cancer
Sponsor: Asan Medical Center
Enrollment: 31
Locations: 1
Primary Endpoint: R0 resection rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

July 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Asan Medical Center

Responsible Party

Principal Investigator

Yoon-Koo Kang

Professor

Asan Medical Center

Eligibility Criteria

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