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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00887822
First received: April 22, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Drug: cisplatin
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival; time to progression; overall response rate; duration of response [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]
  • Adverse events; laboratory parameters [ Time Frame: Throughout study; at each clinic visit ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: March 2009
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
7.5mg/kg every 3 weeks until disease progression
Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle until disease progression
Drug: cisplatin
80mg/m2 iv every 3 weeks for a maximum of 6 cycles, or until disease progression
Placebo Comparator: 2 Drug: capecitabine [Xeloda]
1000mg/m2 po bid on days 1-14 of each 3 week cycle until disease progression
Drug: cisplatin
80mg/m2 iv every 3 weeks for a maximum of 6 cycles, or until disease progression
Drug: Placebo
iv every 3 weeks until disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887822

Locations
China
Beijing, China, 100036
Beijing, China, 100071
Beijing, China, 100021
Beijing, China, 100853
Chongqing, China, 400042
Guangzhou, China, 510060
Hangzhou, China, 310016
Nanjing, China, 210002
Nanjing, China, 210029
Shanghai, China, 200032
Shanghai, China, 200080
Shantou, China, 515041
Shenyang, China, 110001
Wuhan, China, 430030
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00887822     History of Changes
Other Study ID Numbers: ML22367
Study First Received: April 22, 2009
Last Updated: May 7, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Bevacizumab
Cisplatin
Fluorouracil
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013