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Carcinoma, Small CellPhase 2NCT00324558

Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

A Phase 2 study testing Bemiparin in people with Carcinoma, Small Cell, run by Clinica Universidad de Navarra, Universidad de Navarra at 15 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Main objective: To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Small Cell
What is being tested?
Bemiparin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
15 sitesSpain
Study dates
Jun 2005to Sep 2010
Phase
Phase 2
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

  • Patients 18 years old or older, of either sex, with a diagnosis of limited small cell lung cancer.
  • Patients with an ECOG functional state less than or equal to 2.
  • Informed consent to participate in the study.
  • Patients with a platelet count above 100,000/microlitre with no hemorrhagic symptomatology.

Who cannot join

  • Curative or palliative surgery as the initial treatment of their neoplastic condition.
  • Patients with an active hemorrhage in the past two months, organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, aneurysms), history of clinically evident hemorrhagic episodes, major surgery in the past month, outstanding clinically hemoptysis or an increased risk of bleeding due to any homeostatic alteration that contraindicates anticoagulant therapy.
  • Known hypersensitivity to LMWH, heparin or substances of porcine origin.
  • Patients with hypersensitivity to the chemotherapeutic agents used in this protocol that makes it impossible to use the antitumoral regime indicated in this protocol (cisplatin or carboplatin and etoposide), i.e. hypersensitivity to cisplatin and carboplatin or hypersensitivity to etoposide.
  • Patients with congenital or acquired bleeding diathesis.
  • Damage to/ or surgical interventions of the central nervous system, eyes and ears within the past 6 months.
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  • Acute bacterial endocarditis or slow endocarditis.
  • Patients with a history of heparin-associated thrombocytopenia or with a current platelet count < 100,000/mm3
  • Patients with severe renal failure (serum creatinine over 2 mg/dl) or hepatic insufficiency (with values of AST and/or ALT > 5 times the normal value established in the reference range of the local hospital laboratory).
  • Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure above 120 mmHg).
  • Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
  • Patients with suspected inability/or inability to comply with treatment and/or complete the study.
  • Patients who are participating in another clinical trial or have done so in the past 30 days.
  • Patients with a life expectancy less than 3 months.
  • Patients on treatment with anticoagulants or who have been on treatment during three months before the diagnosis of the tumor.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • Hospital General de Alicante

    Alicante, Alicante, 03010

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital Clinic i Provicial de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Universitario Reina Sofía

    Córdoba, Córdoba, 14004

  • Hospital Universitario Carlos Haya

    Málaga, Málaga, 29010

  • Hospital Morales Meseguer

    Murcia, Murcia, 30008

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital de Sagunto

    Port de Sagunt, Valencia, 46520

  • Hospital Clínico Universitario de Puerto Real

    Puerto Real, Cádiz, 11510

  • Hospital Clínico de Salamanca

    Salamanca, Salamanca, 37007

  • Hospital Son Llàtzer

    Son Ferriol, Balearic Islands, 07198

  • Hospital La Fe

    Valencia, Valencia, 46009

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

  • Hospital Río Hortega

    Valladolid, Valladolid, 47010

  • Hospital Clínico Lozano Blesa

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer

Main objective:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT), delays tumoral spread and increases progression-free survival.

Secondary objectives:

To evaluate whether the subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting with the onset of chemotherapy, increases global survival, improving the response rates to treatment with CT + RT (radiotherapy) and reduces the incidence of venous thromboembolism (VTE).

Read the detailed description

There is clinical evidence indicative of the beneficial effects of heparin in the evolution of patients with cancer. Apart from the studies that in an indirect way demonstrated an increase in the survival of oncological patients who, because of presenting a venous thromboembolism episode, were treated with low molecular weight heparin (LMWH) in comparison with those treated with non-fractionated heparin; direct actions were also demonstrated from the use of heparin in the survival and tumour progression. The administration of LMWH together with Chemotherapy has been proved to increase the survival of patients diagnosed of cancer of the pancreas in relation to those only treated with chemotherapy. An increase in the global survival of advanced solid tumours, with no thromboembolic disease,has also been showed.

All this suggests that an improvement in the survival of patients is observed when heparin is added to the usual anti-tumour treatment, especially to those without spread disease, and this effect seems to be independent of the protection against the thromboembolic complications.

Being tested
Bemiparin
Keywords
Bemiparin, small cell lung carcinoma
Medical subject headings
Carcinoma, Small Cell, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BemiparinDrug

    subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)

Study groups in NCT00324558
Study groupRoleWhat they receive
1ExperimentalBemiparin 3,500 IU
Receives: Drug: Bemiparin
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time)

    Measured: efficacy

  2. safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings.

    Measured: safety

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2006 (estimated)
  2. Study startJun 2005
  3. Primary completionFeb 2010
  4. Study completionSep 2010

Why it stopped: Sponsor stopped due to difficulties to recruit 130 patients required by protocol

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324558
Sponsor's protocol ID
ICT-BEM-2004-01
Other IDs
2004-004722-27 (Nº EudraCT), 2004
Status last verified
Jun 2012
First submitted
9 May 2006
Last updated
8 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

    PubMed 33337539

  • Lecumberri R, Lopez Vivanco G, Font A, Gonzalez Billalabeitia E, Gurpide A, Gomez Codina J, Isla D, Galan A, Bover I, Domine M, Vicente V, Rosell R, Rocha E. Adjuvant therapy with bemiparin in patients with limited-stage small cell lung cancer: results from the ABEL study. Thromb Res. 2013;132(6):666-70. doi: 10.1016/j.thromres.2013.09.026. Epub 2013 Sep 27.

    PubMed 24491267

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bemiparin in people with Carcinoma, Small Cell, run by Clinica Universidad de Navarra, Universidad de Navarra at 15 sites in Spain.

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 4 inclusion and 15 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 8 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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: Sponsor stopped due to difficulties to recruit 130 patients required by protocol). 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?

efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (time frame: efficacy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00324558, which also lists 2 linked publications.

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 8 Jun 2012.

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