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
- Conditions
- Subjects enrolled in this study must have histologically confirmed locally advanced or metastatic pancreatic adenocarcinoma. They must not have been received a first-line chemotherapy. Presence of at least one target lesion measurable by CT scan or MRI in not an irradiated area (and conform with the RECIST criteriaMedDRA version: 6.1Level: PTClassification code 10033609
- Registration Number
- EUCTR2007-001781-32-IT
- Lead Sponsor
- GISCAD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: -overall Response Rate (RECIST Criteria)<br><br>-duration of response<br><br>-time to treatment failure<br><br>-overall survival time;Primary end point(s): The primary activity parameter to be determined is Progression Free Survival.;Main Objective: The primary activity parameter to be determined is Progression Free Survival.
- Secondary Outcome Measures
Name Time Method