A pilot study of trastuzumab monotherapy in patients who progressed under a previous platinum-based or 5-fluoropyrimidin-based chemotherapy in metastatic or locally advanced gastric cancer

Hoffmann-La Roche AG0 个研究点目标入组 20 人开始时间: 2005年3月21日最近更新: 2013年4月29日

试验速览

暂无简介。

•Age > 18 years (ethnical group: any; gender: female and male)
•Progression under or after one prior platinum-based or 5-fluoropyrimidine-based chemotherapy in metastatic disease
•At least four weeks from the last platinum-based or 5-fluoropyrimidin-based chemotherapy
•Histological proof of gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction with HER2 overexpression of the primary or metastatic tumor tissue determined by immunohistochemistry and FISH (Score IHC 3+ or Score IHC 2+ and FISH +)
•Metastatic (M1) or locally advanced disease
•At least one measurable lesion evaluable for response (RECIST criteria)
•Estimated life expectancy of > 3 months
•ECOG Performance Status: 0-2
•Adequate cardiac function: LVEF > 50% (detected by echocardiogram)
•Absolute neutrophil count > 1,500/µl
•Absolute platelet count > 100,000 /µl
•Serum total bilirubin: < 2.0 x upper normal limit (UNL)
•Creatinine < 1.5 x UNL
•AST and ALT < 2.5 x UNL; < 5 x UNL in patients with documented liver metastases
•Alkaline phosphatase: < 2.5 UNL
•Negative pregnancy test
•Willingness to give written informed consent, written consent for data protection and willingness to participate and comply with the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Age > 75 years
•Concurrent therapy with any other chemo-/immunotherapeutical regime
•Clinically significant cardiac disease (cardiac insufficiency, NYHA III/IV, uncontrolled arrhythmia or hypertension, symptomatic angina pectoris, clinically significant valvular heart disease, history of congestive heart failure)
•LVEF < 50%
•Pregnant or lactating women
•Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
•Known hypersensitivity reactions to the compounds
•Patients with active or uncontrolled infections/concurrent illness
•Patients with advanced pulmonary disease, severe dyspnoe or requiring oxygen therapy
•Patients with brain or meningeal metastases. Radiologic studies are not required to rule this out unless there is clinical suspicion of CNS disease
•Other co-exisiting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma of cervical cancer in situ. Patients curatively treated and free of disease for at least 5 years will be discussed with the sponsor before inclusion.
•Concomitant or within a 4-week period administration of any other experimental drug under investigation.
•Alcohol and/or drug abuse
•Patients who cannot be regularly observed for psychological, sociological, geographical reasons or other concomitant conditions not permitting adequate follow-up and compliance of the protocol
•patient was already recruited in this trial before

发起方

Hoffmann-La Roche AG