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

Advanced Gastric Cancer Clinical Trial

Official title:

A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471470
• Other study ID #: AMC1003
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Est. completion date: July 2018

Study information

• Verified date: January 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel, 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)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	R0 resection means complete resection of tumor.	Up to 4 weeks after surgery
Secondary	Overall survival	Overall survival will be measured from the start of study treatment to documented death of any cause.	Up to 3 years
Secondary	Progression-free survival	Time to progression will be measured from the start of study treatment to documented tumor progression.	Up to 3 years
Secondary	Adverse Event	Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0	Up to 28 days after end of treatment
Secondary	Angiogenetic biomarkers	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	Baseline and 6 weeks after treatment