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ClinicalTrials.gov Identifier: NCT01058759
Recruitment Status :
(The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.)
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.
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 Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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