Advanced Gastric Cancer
Conditions
Keywords
Advanced gastric cancer, Neoadjuvant, Bevacizumab
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.
Interventions
DRUGDocetaxel, Capecitabine, Cisplatin, Bevacizumab
Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)
Sponsors
Roche Pharma AG
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | Up to 4 weeks after surgery | R0 resection means complete resection of tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 3 years | Overall survival will be measured from the start of study treatment to documented death of any cause. |
| Progression-free survival | Up to 3 years | Time to progression will be measured from the start of study treatment to documented tumor progression. |
| Adverse Event | Up to 28 days after end of treatment | Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0 |
| Angiogenetic biomarkers | Baseline and 6 weeks after treatment | cluster of differentiation 31, microvessel density, platelet derived growth factor, vascular endothelial growth factor-A, vascular endothelial growth factor receptor-1, vascular endothelial growth factor receptor-2, Neuropilin 1 and phosphatidylinositol glycan anchor biosynthesis, class F |
Countries
South Korea
Outcome results
None listed