Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
This trial is active, not recruiting.
|Condition||advanced gastric cancer|
|Treatment||docetaxel, capecitabine, cisplatin, bevacizumab|
|Sponsor||Asan Medical Center|
|Collaborator||Roche Pharma AG|
|Start date||July 2010|
|End date||December 2017|
|Trial size||31 participants|
|Trial identifier||NCT01471470, AMC ONCGI-1003|
The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and bevacizumab are effective in the treatment of unresectable advanced gastric cancer.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
R0 resection rate
time frame: Up to 4 weeks after surgery
time frame: Up to 3 years
time frame: Baseline and 6 weeks after treatment
time frame: Up to 3 years
time frame: Up to 6 months
Male or female participants from 18 years up to 70 years old.
- 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
- 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
|Official title||A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer|
|Principal investigator||Yoon-Koo Kang, MD, PhD|
|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.|
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