A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Cisplatin as First-Line Therapy for Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Double-blind, Randomised, Multicenter, Phase III Study of Bevacizumab in Combination With Capecitabine and Cisplatin Versus Placebo in Combination With Capecitabine and Cisplatin, as First-line Therapy in Chinese Patients With Advanced Gastric Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887822
• Other study ID #: ML22367
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2009
• Last updated: September 1, 2016
• Start date: March 2009
• Est. completion date: August 2014

Study information

• Verified date: September 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the efficacy and safety of Avastin versus placebo, in combination with Xeloda and cisplatin, in patients who have received no prior treatment for advanced or metastatic gastric cancer. Patients will be randomized to receive either Avastin 7.5mg/kg iv or placebo iv, in combination with Xeloda 1000mg/m2 po bid on days 1-14 of each 3 week cycle, and cisplatin 80mg/m2 every 3 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• histologically confirmed cancer of the stomach or gastro-oesophageal junction;

• inoperable, locally advanced or metastatic disease, not amenable to curative therapy;

• ECOG PS of 0,1 or 2.

Exclusion Criteria:

• previous chemotherapy for locally advanced or metastatic gastric cancer;

• previous platinum or anti-angiogenic therapy;

• radiotherapy within 28 days of randomisation;

• evidence of CNS metastasis at baseline.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Placebo
iv every 3 weeks until disease progression
• bevacizumab [Avastin]
7.5mg/kg every 3 weeks until disease progression
• capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle until disease progression
• cisplatin
80mg/m2 iv every 3 weeks for a maximum of 6 cycles, or until disease progression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Event driven; monitored throughout study	No
Secondary	Progression-free survival; time to progression; overall response rate; duration of response		Event driven; monitored throughout study	No
Secondary	Adverse events; laboratory parameters		Throughout study; at each clinic visit	No