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

Asan Medical Center

Status and phase: Completed; Phase 2

Conditions: Advanced Gastric Cancer

Treatments: Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01471470

AMC1003

Details and patient eligibility

About

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

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

neoadjuvant

Experimental group

Treatment:

Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab