Taxotere-Enoxaparin-(ENOXA)-Study

August 21, 2018 updated by: Hannover Medical School

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxonia
      • Hannover, Lower Saxonia, Germany, 30625
        • Hannover Medical School, Department of Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm B: Enoxaparin
Drug: Enoxaparin
Active Comparator: Arm A: No Enoxaparin
Other: No Enoxaparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progressive free survival
Time Frame: monthly
monthly

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Study Chair: Nicolas Dickgreber, MD, Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENOXA-NSCLC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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