A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Adenocarcinoma

In brief

This study will compare treatment with bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin, as first-line therapy in patients with locally advanced or metastatic gastric cancer who had not received prior chemotherapy for advanced or metastatic disease.

Key facts

Study ID

NCT00548548

Run by

Genentech, Inc.

People needed

774

Starts

2007-09-01

Expected to finish

2013-11-01

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 therapy.
• 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.

You may not qualify if…

• 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 (ie, anti-vascular endothelial growth factor [VEGF] or VEGF receptor 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, eg, uncontrolled seizures.
• 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 (ie, active) cardiovascular disease.
• Active infection requiring intravenous antibiotics at randomisation.
• History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
• 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 (eg, 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).

Where it is running

• Tower Cancer Research Fnd — Beverly Hills, California, United States
• Moores UCSD Cancer Center — La Jolla, California, United States
• Kenmar Research Institute LLC — Los Angeles, California, United States
• USC/Norris Cancer Center — Los Angeles, California, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• H. Lee Moffitt Cancer — Tampa, Florida, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Methodist Cancer Center Onc — Omaha, Nebraska, United States
• Memorial Sloan Kettering — New York, New York, United States
• Duke Univ Medical Center — Durham, North Carolina, United States
• South Carolina Oncology Assoc — Columbia, South Carolina, United States
• The Sarah Cannon Research Inst — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.