A randomized phase II study of gemcitabine/cisplatin with or without sorafenib to evaluate the efficacy and safety in patients with locally advanced or metastatic pancreatic cancer. MAPS trial - Metastatic Advanced Pancreas Sorafenib

GISCAD0 个研究点开始时间: 2007年9月7日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Signed written informed consent prior to beginning protocol specific procedures
•Male or female < 75 years of age
•Diagnosis of histologically confirmed adenocarcinoma of the pancreas
•Locally advanced (non-resectable) or metastatic pancreatic cancer
•Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area (RECIST criteria)
•Karnofsky performance status of ≥ 70 at study entry
•Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL
•Bilirubin level either normal or < 1.5 x ULN
•ASAT and ALAT ≤ 2.5 X ULN (≤ 5 x ULN if liver metastasis are present)
•Serum creatinine < 1.5 x ULN
•Amylase and lipase ≤ 1.5 x the upper limit of normal
•PT or INR and PTT < 1.5 x upper limit of normal (subjects who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate provided that no evidence of underlying abnormality in these parameters exists).
•Effective contraception for both male and female patients if the risk of conception exists
•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) no
•F.1.3.1 Number of subjects for this age range

•Brain metastases
•Previous chemotherapy for locally advanced or metastatic pancreatic cancer.
•Adjuvant therapy if documented recurrence is within 6 months after the end of adjuvant treatment)
•Radiotherapy within 4 weeks prior to study entry
•Major surgery within 4 weeks of first dose of study drug
•Concurrent chronic systemic immune therapy
•Any investigational agent(s) 4 weeks prior to entry
•Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
•Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
•Acute or subacute intestinal occlusion or history of inflammatory bowel disease
•Known grade 3 or 4 allergic reaction to any of the components of the treatment
•Known drug abuse/ alcohol abuse
•Legal incapacity or limited legal capacity
•Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
•Women who are pregnant or breastfeeding
•Acute or subacute intestinal occlusion
•Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).

发起方

GISCAD