Taxotere-Enoxaparin-(ENOXA)-Study

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01058759

Enrollment

Registered

2010-01-29

Start date

2009-11-30

Completion date

2011-02-28

Last updated

2018-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, NSCLC, Enoxaparin, Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV

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.

Interventions

DRUGEnoxaparin

OTHERNo Enoxaparin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Progressive free survival	monthly

Secondary

Measure	Time frame
RECIST	monthly
Quality of life	every three months
Overall survival	monthly
safety of long term application of Enoxaparin	monthly
overall toxicity	monthly
thromboembolic complications	monthly

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026