Participants
therapyCapability, gastric adenocarcinoma
DISEASE PROGRESSION, RECURRENCE, LIVER METASTASES, ONCOLOGY, GASTRIC ADENOCARCINOMA
Eligible patients need to fulfill all of the following criteria:
Signed written informed consentWomen or men ≥ 18 years of age; Patients in reproductive age must be willing to use adequate contraception during the study and for 3 months after the end of ramucirumab treatment. Women of childbearing age need to have a negative pregnancy test within 7 days before study start. Patients will be enrolled gender-independently.Proven histology of gastric adenocarcinoma including adenocarcinoma of the esophagogastric junctionMetastatic or locally advanced, inoperable diseaseRadiological or clinical disease progression during or after the last dose of a first-line platinum, fluoropyrimidine-containing therapy. Patients must also have received a taxane with the first-line and/or during their adjuvant or neoadjuvant therapy in a curative setting. Neoadjuvant/adjuvant platinum containing therapy is permitted and is counted as first-line therapy if progression occurs within 12 months after completion of the treatment. The therapy is not considered as a treatment line, if progression or recurrence occurs 12 months after end of last treatment. In case of different prior treatments, they can be considered as one therapy line, if they were administrated as a continuous or alternating therapy.Measurable or non-measurable but evaluable diseaseEastern Cooperative Oncology Group Status must be less than or equal to 0–1Expectancy of life must be less than or equal to 12 weeksReasonable hematological, hepatic and renal functions:Absolute neutrophil count (ANC) ≥ 1.5 x 109/LPlatelets ≥ 100 x 109/LHemoglobin ≥9 g/dL (5.58 mmol/LTotal bilirubin ≤ 1.5 UNLAST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL without liver metastases, or ≤ 5 x UNL in case of liver metastases; AP ≤ 5 x UNLSerum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥40 mL/minuteUrinary protein ≤1+ on dipstick or routine urinalysis; if urine dipstick or routine urine analysis is ≥2+ of urinary protein, patients need a 24-hour urine collection and protein must be below <1000 mg in 24 hoursAn adequate coagulation function measured by the International Normalized Ratio ≤ 1.5 and the partial thromboplastin time ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Patients receiving warfarin/ phenprocoumon must be changed to low molecular weight heparin and need to show a stable coagulation profile before start of first dose of therapyCapability to follow scheduled assessments and to dope with side effects.