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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer
Both
Non-small Cell Lung Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progressive free survival
Outcome Time Frame:
monthly
Safety Issue:
No
Principal Investigator
Nicolas Dickgreber, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Hannover Medical School
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
ENOXA-NSCLC
NCT ID:
NCT01058759
Start Date:
November 2009
Completion Date:
February 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- non-small cell lung cancer
- NSCLC
- Enoxaparin
- Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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