A study of bevacizumab in combination with capecitabine and cisplatin compared to placebo in combination with capecitabine and cisplatin in patients with advanced gastric cancer
- Conditions
- -C16 Malignant neoplasm of stomachMalignant neoplasm of stomachC16
- Registration Number
- PER-088-07
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 5
• 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 and aPTT <1.5 X ULN within 7 days prior to randomization
• Inadequate bone marrow function: ANC <1.5 x 10 ^ / L, platelet count <100 x 10 9 / L or Hb <9 g / dL.
• Inadequate liver function: serum biliimbine (total)> 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+. Patients with> 2+ proteinuria in urinalysis with a dipstick at the baseline visit should undergo 24-hour urine collection and demonstrate <1 g protein / 24 hr.
• Uncontrolled hypertension (systolic> 150 mm Hg and / or diastolic> 100 mm Hg) or clinically significant (ie active) cardiovascular disease, such as cerebrovascular accidents (<6 months before randomization), myocardial infarction (< 6 months prior to randomization), unstable angina, congestive heart failure not higher grade according to the classification of the New York Cardiology Association (NYHA Appendix 5), or serious cardiac arrhythmia not controlled by medication or potentially interfering with the treatment of the protocol.
• Active infection that requires intravenous antibiotics at the time of randomization.
• History or evidence of inherited hemorrhagic diathesis or coagulopathy with risk of hemorrhage.
• Serious or unhealed wound, peptic ulcer, or bone fracture (not completely healed).
• Active gastrointestinal bleeding.
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization.
• Neuropathy (e.g., hearing and balance impairment)> grade II according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method