Back to resultsTaxotere-Enoxaparin-(ENOXA)-Study
Primary Purpose
Non-small Cell Lung Cancer
Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Enoxaparin
No Enoxaparin
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell lung cancer, NSCLC, Enoxaparin, Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent
- Men and women aged 18 and older
- Locally Advanced or Metastatic Non-small Cell Lung Cancer stage IIIB/IV without any previous therapy
- Life expectancy at least 12 weeks
- EOCG performance < 1
- Appropriate renal and hepatic function
- Appropriate Hematology
- No bleeding events within 4 weeks prior to randomization
- No indication for prophylactic or therapeutic anticoagulation therapy
- Appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
- Capability for s.c. injection of Enoxaparin every 24 hrs
Exclusion Criteria:
- History of cancer other than NSCLC
- Known contraindication for Enoxaparin e.g. HIT,
- Known contraindication for Docetaxel, Cisplatin, Carboplatin or co-medication
- Participation in any other clinical trials within 30 days prior to randomization
- Any known medical condition that does not allow therapy according to study protocol
- Seizure disorder
Sites / Locations
- Hannover Medical School, Department of Pneumology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm B: Enoxaparin
Arm A: No Enoxaparin
Arm Description
Outcomes
Primary Outcome Measures
Progressive free survival
Secondary Outcome Measures
Overall survival
RECIST
Quality of life
thromboembolic complications
safety of long term application of Enoxaparin
overall toxicity
Full Information
NCT ID
NCT01058759
First Posted
January 28, 2010
Last Updated
August 21, 2018
Sponsor
Hannover Medical School
1. Study Identification
Unique Protocol Identification Number
NCT01058759
Brief Title
Taxotere-Enoxaparin-(ENOXA)-Study
Official Title
Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as Single Therapy or in Combination With Enoxaparin in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, a Phase III Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or metastatic non-small cell lung cancer (stadium IIIb/IV), a phase III study. Study hypothesis: Increase of progressive free survival from 5 to 7.5 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
non-small cell lung cancer, NSCLC, Enoxaparin, Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm B: Enoxaparin
Arm Type
Experimental
Arm Title
Arm A: No Enoxaparin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Type
Other
Intervention Name(s)
No Enoxaparin
Primary Outcome Measure Information:
Title
Progressive free survival
Time Frame
monthly
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
monthly
Title
RECIST
Time Frame
monthly
Title
Quality of life
Time Frame
every three months
Title
thromboembolic complications
Time Frame
monthly
Title
safety of long term application of Enoxaparin
Time Frame
monthly
Title
overall toxicity
Time Frame
monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
Men and women aged 18 and older
Locally Advanced or Metastatic Non-small Cell Lung Cancer stage IIIB/IV without any previous therapy
Life expectancy at least 12 weeks
EOCG performance < 1
Appropriate renal and hepatic function
Appropriate Hematology
No bleeding events within 4 weeks prior to randomization
No indication for prophylactic or therapeutic anticoagulation therapy
Appropriate methods of contraception (both: men and women) for women of childbearing potential negative urine pregnancy test within 7 day prior to randomization
Capability for s.c. injection of Enoxaparin every 24 hrs
Exclusion Criteria:
History of cancer other than NSCLC
Known contraindication for Enoxaparin e.g. HIT,
Known contraindication for Docetaxel, Cisplatin, Carboplatin or co-medication
Participation in any other clinical trials within 30 days prior to randomization
Any known medical condition that does not allow therapy according to study protocol
Seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Dickgreber, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Hannover Medical School, Department of Pneumology
City
Hannover
State/Province
Lower Saxonia
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Taxotere-Enoxaparin-(ENOXA)-Study
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