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

CompletedPhase 2

Sponsor: Asan Medical Center

Conditions: Advanced Gastric Cancer

Interventions: Docetaxel, Capecitabine, Cisplatin, Bevacizumab

Countries: South Korea

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

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Seoul, South Korea