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Taxotere-Enoxaparin-(ENOXA)-Study

This study has been terminated.
(The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058759
First Posted: January 29, 2010
Last Update Posted: November 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hannover Clinical Trial Center GmbH
Information provided by (Responsible Party):
Hannover Medical School
  Purpose
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.

Condition Intervention Phase
Non-small Cell Lung Cancer Drug: Enoxaparin Other: No Enoxaparin Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Progressive free survival [ Time Frame: monthly ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: monthly ]
  • RECIST [ Time Frame: monthly ]
  • Quality of life [ Time Frame: every three months ]
  • thromboembolic complications [ Time Frame: monthly ]
  • safety of long term application of Enoxaparin [ Time Frame: monthly ]
  • overall toxicity [ Time Frame: monthly ]

Enrollment: 14
Study Start Date: November 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm B: Enoxaparin Drug: Enoxaparin
Active Comparator: Arm A: No Enoxaparin Other: No Enoxaparin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058759


Locations
Germany
Hannover Medical School, Department of Pneumology
Hannover, Lower Saxonia, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Hannover Clinical Trial Center GmbH
Investigators
Study Chair: Nicolas Dickgreber, MD Hannover Medical School
  More Information

Responsible Party: Hannover Medical School, MD
ClinicalTrials.gov Identifier: NCT01058759     History of Changes
Other Study ID Numbers: ENOXA-NSCLC
First Submitted: January 28, 2010
First Posted: January 29, 2010
Last Update Posted: November 11, 2011
Last Verified: November 2011

Keywords provided by Hannover Medical School:
non-small cell lung cancer
NSCLC
Enoxaparin
Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action