EUCTR2010-020979-23-IT
Active, Not Recruiting
N/A
Randomized fase II study using chemiotherapy with metformine in patients affected by pancreas metastatic cancer. - ND
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 sitesJuly 16, 2010
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- pancreas metastatic tumor
- Sponsor
- FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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