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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 Patients With Advanced Gastric Cancer

Phase 3
18 Years
Open (Enrolling)

Thank you

Trial Information

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 Patients With Advanced Gastric Cancer

This was a two arm, randomized, double-blind, multicenter phase III study. Patients were
randomized (1:1) to capecitabine/cisplatin plus bevacizumab or capecitabine/cisplatin plus
placebo. This was an event-driven trial with the final analysis (triggering the end of the
study) planned after approximately 517 deaths had been observed. After final analysis the
study will remain open and patients can continue with study treatment until progressive
disease or earlier at the investigators discretion. After discontinuation of the last
patient, the study will end globally.

Inclusion Criteria:

- Written informed consent obtained prior to any study specific procedures

- Age ≥ 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

- Life expectancy of at least 3 months

- Able to comply with the protocol

- Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction
with inoperable, locally advanced or metastatic disease, not amenable to curative

- Measurable disease or non-measurable but evaluable disease, according to the Response
Evaluation Criteria in Solid Tumours (RECIST)

- Patient not receiving anticoagulant medication must have an International normalized
ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x Upper
Limit of Normal (ULN) within 7 days prior to randomisation

Exclusion Criteria:

- Previous chemotherapy for locally advanced or metastatic gastric cancer. Patients may
have received prior neoadjuvant or adjuvant chemotherapy as long as it was completed
at least 6 months prior to randomisation

- Previous platinum or anti-angiogenic therapy (i.e. anti-VEGF or VEGFR tyrosine kinase
inhibitor etc)

- Patients with locally advanced disease who are candidates for curative therapy
(including operation and/or chemotherapy and/or radiotherapy)

- Radiotherapy within 28 days of randomisation

- Major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to randomisation, or anticipation of the need for major surgery during the
course of the study treatment (planned elective surgery)

- Minor surgical procedures within 2 days prior to randomisation

- Evidence of central nervous system (CNS) metastasis at baseline

- History or evidence upon physical/neurological examination of CNS disease unrelated
to cancer unless adequately treated with standard medical therapy, e.g. uncontrolled

- History of another malignancy which could affect compliance with the protocol or
interpretation of results

- Inadequate bone marrow function

- Inadequate liver function

- Inadequate renal function

- Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular

- Active infection requiring intravenous antibiotics at randomisation

- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of

- Serious or non-healing wound, peptic ulcer, or (incompletely healed) bone fracture

- Active gastrointestinal bleeding

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months of randomisation

- Neuropathy (e.g. impairment of hearing and balance) ≥ grade II according to Common
Terminology Criteria for Adverse Events (CTCAE) v3.0

- Chronic daily treatment with aspirin or clopidogrel

- Chronic daily treatment with oral corticosteroids; inhaled steroids and short courses
of oral steroids for anti-emesis or as an appetite stimulant are allowed

- Known hypersensitivity to any of the study drugs or excipients or to Chinese hamster
ovary cell products or to other recombinant human or humanised antibodies

- Known dihydropyrimidine dehydrogenase (DPD) deficiency

- Evidence of any other disease, metabolic or psychological dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates use of an investigational drug, or that may
affect patient compliance with the study, or place the patient at high risk from
treatment complications

- Known acute or chronic-active infection with Hepatitis B Virus (HBV) or Hepatitis C
Virus (HCV)

- Pregnant or lactating females

- Women of childbearing potential not using effective nonhormonal (intrauterine
contraceptive device, barrier method of contraception in conjunction with spermicidal
jelly or surgically sterile) means of contraception

- Sexually active men unwilling to practice contraception during the study

- Current or recent (within the 28 days prior to randomisation) treatment with another
investigational drug or participation in another investigational study

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

The primary efficacy endpoint for this study was overall survival (time to death), defined as the time between randomization and the date of death irrespective of the cause of death. Patients for whom no death was captured on the clinical database were censored at the most recent date they were known to be alive. Median survival was estimated by the Kaplan-Meier method.

Outcome Time Frame:

From randomization until death, up to 26 months

Safety Issue:


Principal Investigator

Eric Hedrick, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

Related Keywords:

  • Adenocarcinoma
  • Avastin
  • Metastatic Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms



Florida Cancer Specialists Fort Myers, Florida  33901
Moores UCSD Cancer Center La Jolla, California  92093-0658
Georgetown University Washington, District of Columbia  20007-2197
USC/Norris Cancer Center Los Angeles, California  
Cancer Center of Kansas Wichita, Kansas  67214
Memorial Sloan Kettering New York, New York  10021
South Carolina Oncology Assoc Columbia, South Carolina  29210
Kenmar Research Institute LLC Los Angeles, California  90057
Tower Cancer Research Fnd Beverly Hills, California  90211-1850
H. Lee Moffitt Cancer Tampa, Florida  33612
Methodist Cancer Center Onc Omaha, Nebraska  68114
Duke Univ Medical Center Durham, North Carolina  27710
The Sarah Cannon Research Inst Nashville, Tennessee  37203