Randomized fase II study using chemiotherapy with metformine in patients affected by pancreas metastatic cancer. - ND

• Conditions: pancreas metastatic tumor; MedDRA version: 9.1Level: HLTClassification code 10033632

• Registration Number: EUCTR2010-020979-23-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-cytologic and istologic diagnosis of pancreatic adenocarcinoma; -presence of metasatasis; -absebce of crebral metastasis with symptoms; -age between 18-75 yeras old (71-75 only if KPS>70%); -Karnofsky PS > 60 ; -measurable disease; -GB > 3500/mm3, neutrofili > 1500/mm3; Plt > 100000/mm3; Hb > 10 g/dl; -creatinine < 1.5 mg/dL; bilirubine < 2 mg/dL; SGOT e SGPT < 3 UNL; -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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-previous metformine assumption; -previous or concomitant malignant tumors, apart from carcinoma in sito of the uterine cervix and epitelial malignant tumors adeguately treated or other malignant tumors if patiet was free from pathology from almost 5 years ; -pregnancy and breast feeding; -counter-indications for chemiotherapic treatment (acute heart attack 4 months before the study enrollment, heart failure; -alcool abuse;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified