Non-small Cell Lung CancerPhase 3NCT01058759
Taxotere-Enoxaparin-(ENOXA)-Study
A Phase 3 study testing Enoxaparin and No Enoxaparin in people with Non-small Cell Lung Cancer, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Enoxaparin and No Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Department of Pneumology
Hanover, Lower Saxonia, 30625
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Enoxaparin, No Enoxaparin
- Keywords
- non-small cell lung cancer, NSCLC, Enoxaparin, Locally Advanced or Metastatic Non-small Cell Lung Cancer stadium IIIb/IV
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
No EnoxaparinOther
| Study group | Role | What they receive |
|---|---|---|
| Arm B: Enoxaparin | Experimental | Not described Receives: Drug: Enoxaparin |
| Arm A: No Enoxaparin | Active comparator | Not described Receives: Other: No Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive free survival
Measured: monthly
Secondary outcomes (6)
Overall survival
Measured: monthly
RECIST
Measured: monthly
Quality of life
Measured: every three months
thromboembolic complications
Measured: monthly
safety of long term application of Enoxaparin
Measured: monthly
overall toxicity
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Dickgreber, MD, Study chair, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058759
- Sponsor's protocol ID
- ENOXA-NSCLC
- Status last verified
- Aug 2018
- First submitted
- 28 Jan 2010
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01058759
- Acronym / sponsor ID
- ENOXA-NSCLC
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B: Enoxaparin | Experimental | Drug: Enoxaparin |
| Arm A: No Enoxaparin | Active comparator | Other: No Enoxaparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin | Drug | Arm B: Enoxaparin |
| No Enoxaparin | Other | Arm A: No Enoxaparin |
Primary outcome
Progressive free survival
Time frame: monthly
6 secondary outcomes
Overall survival
Time frame: monthly
RECIST
Time frame: monthly
Quality of life
Time frame: every three months
thromboembolic complications
Time frame: monthly
safety of long term application of Enoxaparin
Time frame: monthly
overall toxicity
Time frame: monthly
Results and safety
The study was stopped early (reason given: The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Dickgreber, MD study chair
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enoxaparin and No Enoxaparin in people with Non-small Cell Lung Cancer, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The external funding (pharmaceutical company) was stopped and could not be substituded by internal funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive free survival (time frame: monthly). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.