Taxotere-Enoxaparin-(ENOXA)-Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Enoxaparin
* Other: No Enoxaparin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm B: Enoxaparin<br> | Drug: Enoxaparin<br> <br> |
| Active Comparator: Arm A: No Enoxaparin<br> | Other: No Enoxaparin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive free survival |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | monthly | 
| RECIST |  | monthly | 
| Quality of life |  | every three months | 
| thromboembolic complications |  | monthly | 
| safety of long term application of Enoxaparin |  | monthly | 
| overall toxicity |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, NSCLC, Enoxaparin, Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV