A Multicenter, Phase II, Single-Arm Clinical Trial of nab-Paclitaxel as salvage treatment for patients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junction - N/A

Hellenic Oncology Research Group (H.O.R.G.)0 个研究点开始时间: 2012年8月8日最近更新: 2016年5月2日

适应症

试验速览

暂无简介。

•Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
•Age > 18 years old
•Assessable target lesion(s) as defined by RECIST criteria v1.1
•Disease progression after treatment with the DCF regimen
•ECOG performance status = 1
•Hgb = 8g/dL, WBC = 3 x 109/L , neutrophils count = 1.5 x 109/L , platelets =100 x 109/L
•Creatinine clearance =50 mL/min
•Total bilirubin = 1.5 X UNL
•AST, ALT and ALP = 2.5 x UNL
•Estimated life expectancy more than 3 months
•Written informed consent
•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 59
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 59

•Gastrointestinal bleeding
•Clinically relevant, symptomatic excessive amounts of ascites resulting in patient’s discomfort
•CNS metastases
•Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
•Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
•Known hypersensitivity reaction to the component of the treatment.
•Active infection or malnutrition or bowel obstruction.
•Legal incapacity or limited legal capacity
•Definite contraindications for the use of corticosteroids
•History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
•Chronic inflammation of the bowel.
•Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment
•Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent.
•Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer.

发起方

Hellenic Oncology Research Group (H.O.R.G.)