Taxotere-Enoxaparin-(ENOXA)-Study

Hannover Medical School (MHH)

Status and phase

Terminated

Phase 3

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Enoxaparin

Other: No Enoxaparin

Study type

Interventional

Funder types

Other

Identifiers

NCT01058759

ENOXA-NSCLC

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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