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

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: Roche Pharma AG
• Treatments: Bevacizumab; Capecitabine; Cisplatin; Docetaxel

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