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Taxotere-Enoxaparin-(ENOXA)-Study

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ClinicalTrials.gov Identifier: NCT01058759
Recruitment Status : Terminated (The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.)
First Posted : January 29, 2010
Last Update Posted : November 11, 2011
Sponsor:
Collaborator:
Hannover Clinical Trial Center GmbH
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Enoxaparin Other: No Enoxaparin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Arm B: Enoxaparin Drug: Enoxaparin
Active Comparator: Arm A: No Enoxaparin Other: No Enoxaparin



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

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: monthly ]
  2. RECIST [ Time Frame: monthly ]
  3. Quality of life [ Time Frame: every three months ]
  4. thromboembolic complications [ Time Frame: monthly ]
  5. safety of long term application of Enoxaparin [ Time Frame: monthly ]
  6. overall toxicity [ Time Frame: monthly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: Hannover Medical School, MD
ClinicalTrials.gov Identifier: NCT01058759     History of Changes
Other Study ID Numbers: ENOXA-NSCLC
First Posted: January 29, 2010    Key Record Dates
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