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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:
Collaborator:
Hannover Clinical Trial Center GmbH
Information provided by (Responsible Party):
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01058759
First received: January 28, 2010
Last updated: November 10, 2011
Last verified: November 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • RECIST [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: every three months ] [ Designated as safety issue: No ]
  • thromboembolic complications [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • safety of long term application of Enoxaparin [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • overall toxicity [ Time Frame: monthly ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hannover Medical School, MD
ClinicalTrials.gov Identifier: NCT01058759     History of Changes
Other Study ID Numbers: ENOXA-NSCLC
Study First Received: January 28, 2010
Last Updated: November 10, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 23, 2014