Taxotere-Enoxaparin-(ENOXA)-Study

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01058759
• Other study ID #: ENOXA-NSCLC
• Status: Terminated
• Phase: Phase 3
• Start date: November 2009
• Est. completion date: February 2011

Study information

• Verified date: August 2018
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Enoxaparin

Other:
• No Enoxaparin

Locations

Country	Name	City	State
Germany	Hannover Medical School, Department of Pneumology	Hannover	Lower Saxonia

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Hannover Clinical Trial Center GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progressive free survival		monthly
Secondary	Overall survival		monthly
Secondary	RECIST		monthly
Secondary	Quality of life		every three months
Secondary	thromboembolic complications		monthly
Secondary	safety of long term application of Enoxaparin		monthly
Secondary	overall toxicity		monthly