Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor
Primary Purpose
Unknown Primary Tumors
Status
Withdrawn
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Cisplatin
Paclitaxel
Gemcitabine
Avastin (Bevacizumab)
Sponsored by
About this trial
This is an interventional treatment trial for Unknown Primary Tumors
Eligibility Criteria
Inclusion Criteria:
- Unknown primary tumors
- ECOG performance status 0-1
- Adequate kidney, liver and bone marrow function
- No prior chemotherapy
- Life expectancy > 3 months
Exclusion Criteria:
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
Sites / Locations
- Rigshospitalet, Dept of Oncology
Outcomes
Primary Outcome Measures
Progression Free Survival
Response
Secondary Outcome Measures
Toxicity
Response Duration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00458315
Brief Title
Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor
Official Title
Randomized Fase II Trial: Comparing Cisplatin, Paclitaxel and Gemcitabine Versus Cisplatin, Paclitaxel, Gemcitabine and Avastin in Patients With Unknown Primary Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Withdrawn
Why Stopped
never been started
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
May 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
Paclitaxel 175 mg/m2 IV infusion, Day 1
Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8
Arm B: Cisplatin, Paclitaxel, Gemcitabine and Avastin (Bevacizumab)
Cisplatin 75 mg/m2 IV infusion, Day 1
Paclitaxel 175 mg/m2 IV infusion, Day 1
Gemcitabine 1000 mg/m2 IV infusion, Day 1 and 8
Bevacizumab 7,5 mg/m2 IV infusion, Day 1
Patients will be stratified by number of metastatic sites (one versus two or more) and the level of Lactate Dehydrogenase (normal versus high).
The regimens will be repeated every 21 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unknown Primary Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Avastin (Bevacizumab)
Primary Outcome Measure Information:
Title
Progression Free Survival
Title
Response
Secondary Outcome Measure Information:
Title
Toxicity
Title
Response Duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unknown primary tumors
ECOG performance status 0-1
Adequate kidney, liver and bone marrow function
No prior chemotherapy
Life expectancy > 3 months
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gedske Daugaard, MD
Organizational Affiliation
Rigshospitalet, Dept of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Dept of Oncology
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Cisplatin/Paclitaxel/Gemcitabine +/- Avastin in Patients With Unknown Primary Tumor
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