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Fase II trial with gemcitabine and oxaliplatin in patients with unknown primary tumours - UPT - unfit

Phase 1
Conditions
To test the effect of Gemcitabine and axaliplatin in patients with unknown primary tumours and performance 2 or age 66 to 75
Registration Number
EUCTR2005-001959-38-DK
Lead Sponsor
Gedske Daugaard
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
39
Inclusion Criteria

Unknown primary tumour
Performance 2 or age 66 to 75
Measurable lesion by RECIST
Expected life time more than 12 weeks
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

Performance 0 or 1 and age below 66
neuropathy
another known cancer disease

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: response rate<br>;Secondary Objective: side effects<br>time to progression;Primary end point(s): response rate
Secondary Outcome Measures
NameTimeMethod
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