Status:
COMPLETED
Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01471470
Start Date
July 1 2010
End Date
July 1 2018
Last Update
January 7 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736