Taxotere-Enoxaparin-(ENOXA)-Study

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hannover Medical School
• Collaborator: Hannover Clinical Trial Center GmbH
• Treatments: Docetaxel; Enoxaparin; Enoxaparin sodium

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