To investigate bevacizumab in combination with carboplatin and capecitabine for patients with unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to standard chemotherapy for this patient population we will improve Progression Free Survival by 90% over historical controls.
Primary Objectives: To investigate if the addition of Bevacizumab to standard chemotherapy for metastatic or unresectable GEJ and gastric adenocarcinoma will improve PFS by 90% over historical controls. Secondary Objectives: * Assess toxicities using CTCAE v3.0 * Evaluate overall survival (OS) using Kaplan-Meier analysis * Evaluate objective response rate (RR) by RECIST criteria * Explore biomarkers of tumor response: CEA, CA 19.9, and serum VEGF * Bank serum and tissue for future correlative studies * Evaluate CT Perfusion to predict early therapeutic response to combination chemotherapy and anti-angiogenic therapy (OPTIONAL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Intravenous 15 mg/kg
AUC 6, Intravenously Day 1 every 21 days
850mg/m2, Orally twice daily days 1-14 every 21 days.
Stanford University School of Medicine
Stanford, California, United States
Progression-Free Survival (PFS)
Tumor progression was assessed according to the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), presented below. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Objective Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria. Progression-Free Survival is assessed as the number of evaluable participants who were alive without disease progression at 1 year. Participants without out assessment at 12 months will not be included.
Time frame: 12 months
Adverse Events ≥ Grade 3 and Related to Bevacizumab
Toxicity was assessed as the number of adverse events ≥ Grade 3 and also possibly, probably, or definitely related to bevacizumab. The outcome is reported as the total number of applicable events, and as the number of events that were a hematologic toxicity; a non-hematologic toxicity; which are numbers without dispersion.
Time frame: 12 months
Overall Survival (OS)
Overall survival (OS) will be assessed from time from the date of enrollment to the date of death due to any cause or the last date the patient was known to be alive (censored observation) at the date of data cutoff for the final analysis. The outcome is presented as the median survival in days with standard deviation.
Time frame: 7.5 years
Objective (Overall) Therapeutic Response
Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions, and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays/radiologic scan. Response was determined based on the criteria below. * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Objective Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is provided as the number of participants who achieved each of the defined responses, with objective (overall) response defined as the sum of CR and PR. The outcome is reported as values without dispersion.
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Time frame: 12 months
CEA and CA 19.9 Tumor Response Biomarkers
The detected blood levels for tumor biomarkers CEA and CA 19.9 were to be correlated to the results for progression-fee survival (PFS), with the outcome presented as the median with standard deviation.
Time frame: 9 weeks
Vascular Endothelial Growth Factor Tumor Response Biomarker
The detected blood levels for tumor biomarker vascular endothelial growth factor (VEGF) were to be correlated to the results for progression-fee survival (PFS), with the outcome presented as the median with standard deviation.
Time frame: 9 weeks