Taxotere-Enoxaparin-(ENOXA)-Study

Phase 3

Terminated

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: No Enoxaparin; Drug: Enoxaparin

• Registration Number: NCT01058759
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: No Enoxaparin	No Enoxaparin	-
Arm B: Enoxaparin	Enoxaparin	-

Primary Outcome Measures

Name	Time	Method
Progressive free survival	monthly

Secondary Outcome Measures

Name	Time	Method
overall toxicity	monthly
Overall survival	monthly
RECIST	monthly
Quality of life	every three months
thromboembolic complications	monthly
safety of long term application of Enoxaparin	monthly

Trial Locations

Locations (1)

Hannover Medical School, Department of Pneumology; 🇩🇪 Hannover, Lower Saxonia, Germany