Randomized fase II trial: comparing Cisplatin, Paclitaxel and Gemcitabine vs. Cisplatin, Paclitaxel, Gemcitabine and Avastin in patients with unknown primary tumors
- Conditions
- To test in a randomized fase II trial the effect of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin in patients with unknown primary tumors between the age of 18 and 70 years old and with a perfomance status 0-1
- Registration Number
- EUCTR2007-000663-18-DK
- Lead Sponsor
- Rigshospitalet, Onkologisk Klinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
unknown primary tumor
Performance status 0-1
Age between 18 and 70 years old
Measurable lesion by RECIST
Life expectancy > 3 months
Sufficient organ functions
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 status > 1
older than 70 years old
Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding
Use of ASA, NSAIDs or clopidogrel
Any other active malignancy, except basal or squamous cell carcinoma of the skin, or carcinoma in situ
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method