Status:
WITHDRAWN
Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Unknown Primary Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the efficacy of Cisplatin, Paclitaxel, Gemcitabine +/- Avastin (Bevacizumab) in patients with unknown primary tumors.
Detailed Description
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms: Arm A: Cisplatin, Paclitaxel and Gemcitabine * Cisplatin 75 mg/m2 IV infusion, Day 1 * Paclita...
Eligibility Criteria
Inclusion
- Unknown primary tumors
- ECOG performance status 0-1
- Adequate kidney, liver and bone marrow function
- No prior chemotherapy
- Life expectancy \> 3 months
Exclusion
- The following specific syndromes:
- Squamous carcinoma limited to cervical glands
- Women with adenocarcinoma isolated to axillary nodes
- Women with adenocarcinoma isolated to peritoneal involvements
- Young men (\<55 years) with growing mid-line tumors where a germ cell tumor could be expected
- Neuroendocrine carcinomas
- Tumor located close to major blood vessels and judged to possess a high risk of serious bleeding
- Any significant cardiac disease
- Clinically significant peripheral vascular disease
- History of myocardial infarction or stroke within 6 months
- Evidence of coagulopathy
- Use of ASA, NSAIDs or clopidogrel
- Pregnancy or breast feeding
- Ongoing therapeutic anti-coagulation
- Hypertension with blood pressure \> 150/100 mmHg
- Brain metastases
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00458315
Start Date
May 1 2007
End Date
May 1 2012
Last Update
May 8 2015
Active Locations (1)
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1
Rigshospitalet, Dept of Oncology
Copenhagen, Denmark, 2100