None listed
Conditions
Interventions
Group 1 Type of group
capecitabine 1000 mg / m2 twice a day p.o.r. 1-14 days + cisplatin 80 mg / m2 2 hr i.v. day 1 + bevacizumab 7.5 mg / kg i.v. day 1 for 18 weeks
Group name:Group 2 Type of group
capecitabine 1000 mg / m2 twice a day p.o.r. 1-14 days + cisplatin 80 mg / m2 2 hr i.v. day 1 + placebo for 18 weeks
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent obtained before performing any specific procedure of the study (the informed consent document must be approved by the Ethics Committee / Institutional Research Council of the institution (lEC / IRB)) • Age> 18 years • ECOGPS ofO, 1 or2 • Life expectancy of at least 3 months • Ability to comply with the protocol • Gastric adenocarcinoma or gastroesophageal junction * advanced locally or metastatic, histologically confirmed and inoperable, with no possibility of curative treatment. • Measurable disease or disease not measurable but evaluable, according to the criteria for evaluating the response in solid tumors (RECIST). In general, patients with peritoneal disease are considered as patients with evaluable disease who are allowed to enter the study. • Patients who do not receive anticoagulant medication must have an INR 1.5 x ULN, ASI and ALT> 2.5 x ULN (> 5 X ULN in patients with liver metastases), alkaline phosphatase> 2.5 x ULN or> 5 X ULN in case of liver metastasis or> 10 x ULN in case of bone metastasis. • Inadequate renal function: Creatinine clearance should be> 60 ml / min. It is recommended to use the Cockroft and Gault formula to calculate creatinine clearance. Patients with creatinine clearance just below 60 ml / min may be candidates if a measured creatinine clearance (based on 24-hour urine collection or other reliable method) is> 60 ml / min. The Urine Test with dipstick for proteinuria should be 2+ proteinuria in urinalysis with a dipstick at the baseline visit should undergo 24-hour urine collection and demonstrate 150 mm Hg and / or diastolic> 100 mm Hg) or clinically significant (ie active) cardiovascular disease, such as cerebrovascular accidents ( grade II according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Exclusion criteria
Exclusion criteria: • Previous chemotherapy for advanced gastric cancer at the local or metastatic level. Patients may have received neoadjuvant or adjuvant chemotherapy previously provided it has been completed at least 6 months before randomization. • Previous anti angiogenic treatment or previous platinum treatment (ie, anti-VEGF or VEGFR tyrosine kinase inhibitor, etc.). • Patients with advanced disease locally who are candidates for curative treatment (including surgery and / or chemotherapy and / or radiotherapy). • Radiation therapy within 28 days prior to randomization. Patients who have received palliative radiotherapy at peripheral sites (e.g., bone metastases) may enter the study within 28 days but must have recovered from any reversible acute effect. • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipated knowledge of the need for major surgery within the course of the study (planned elective surgery). • Minor surgical procedure within 2 days prior to randomization (including placement of CVAD for the administration of chemotherapy). • Evidence of metastasis to the CNS at the baseline visit. It is mandatory to perform a CT or MRI within 28 days prior to randomization to rule out involvement of the CNS in case of clinical suspicion of CNS metastasis. • Background or evidence at the time of physical / neurological examination of CNS disease not related to cancer, unless it is adequately controlled with standard medical treatment, e.g. uncontrolled seizures • Antecedents of another malignant tumor that could affect the attachment of the protocol or the interpretation of the results. Generally speaking, patients are candidates if they have had non-melanoma skin cancer, carcinoma in situ of the cervix, or other tumor • Chronic daily treatment with aspirin (> 325 mg / day) or clopidogrel (> 75 mg / day). • Chronic daily treatment with oral corticosteroids (dose of> 10 mg / day of methylprednisolone equivalent). Inhaled steroids and small doses of oral steroid are allowed as an antiemetic or as an appetite stimulant. • Known hypersensitivity to any of the study drugs or excipients or to Chinese hamster ovary cell products or to other human or humanized recombinant antibodies. • Known deficiency of dihydropyrimidine dehydrogenase (DPD). • Evidence of any other disease, metabolic or psychological dysfunction, finding on physical examination, or clinical laboratory finding that generates reasonable suspicion of a disease or condition that contraindicates the use of a research drug, or that could affect the attachment of the study, or that puts the patient at high risk for complications of treatment. • Knowledge of acute or chronic active HBV or HCV infection. • Pregnant or lactating women. • Women of childbearing age (<2 years after the last menstruation) who are not using a non-hormonal method of contraception (intrauterine device, barrier method of contraception together with spermicidal gel, or sterile surgically). • Sexually active men who are not willing to practice contraception during the study. • Current or recent treatment (within 28 days prior to randomization) with another investigational medication or participation in another research study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Frogression free survival Median time to event (months) Measure:Overall survival Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Median time to event (months) Measure:Progression-free survival (PFS) Timepoints:After treatment ; Outcome name:Median time to event (months) Measure:Time to progression Timepoints:After treatment ; Outcome name:Median time to event (months) Measure:Duration of response during first line therapy Timepoints:After treatment ; Outcome name:Best overall response Responders (CR or PR) 95% CI Difierence in response rates (95% CI for diiference) Chisquared test p-value Measure:Best overall response Timepoints:During treatment ; Outcome name:Patients with disease control Measure:Disease control rate Timepoints:During treatment | — |
Countries
Australia, Belgium, Brazil, China, Costa Rica, France, Germany, Italy, Japan, Russian Federation, Singapore, Spain, Taiwan, United Kindgdom, United States
Contacts
Public ContactPILAR RIVERA
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed