Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

Study Description

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Brief 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.

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).

Condition or disease	Intervention/treatment	Phase
Carcinoma, Small Cell	Drug: Bemiparin	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	39 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	June 2005
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	September 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; Bemiparin 3,500 IU	Drug: Bemiparin; subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)
No Intervention: Control

Outcome Measures

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Primary Outcome Measures :

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) [ Time Frame: 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. [ Time Frame: safety ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Curative or palliative surgery as the initial treatment of their neoplastic condition.
2. 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.
3. Known hypersensitivity to LMWH, heparin or substances of porcine origin.
4. 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.
5. Patients with congenital or acquired bleeding diathesis.
6. Damage to/ or surgical interventions of the central nervous system, eyes and ears within the past 6 months.
7. Acute bacterial endocarditis or slow endocarditis.
8. Patients with a history of heparin-associated thrombocytopenia or with a current platelet count < 100,000/mm3
9. 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).
10. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure above 120 mmHg).
11. Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
12. Patients with suspected inability/or inability to comply with treatment and/or complete the study.
13. Patients who are participating in another clinical trial or have done so in the past 30 days.
14. Patients with a life expectancy less than 3 months.
15. Patients on treatment with anticoagulants or who have been on treatment during three months before the diagnosis of the tumor.

Contacts and Locations

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Locations

Spain
Hospital Clínico Universitario de Puerto Real
Puerto Real, Cádiz, Spain, 11510
Hospital Universitario Reina Sofía
Cordoba, Córdoba, Spain, 14004
Hospital Son Llàtzer
Son Ferriol, Islas Baleares, Spain, 07198
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31008
Hospital de Sagunto
Puerto de Sagunto, Valencia, Spain, 46520
Hospital de Cruces
Barakaldo, Vizcaya, Spain, 48903
Hospital General de Alicante
Alicante, Spain, 03010
Hospital Clinic i Provicial de Barcelona
Barcelona, Spain, 08036
Hospital Morales Meseguer
Murcia, Spain, 30008
Hospital Universitario Carlos Haya
Málaga, Spain, 29010
Hospital Clínico de Salamanca
Salamanca, Spain, 37007
Hospital La Fe
Valencia, Spain, 46009
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Río Hortega
Valladolid, Spain, 47010
Hospital Clínico Lozano Blesa
Zaragoza, Spain, 50009

Sponsors and Collaborators

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

Principal Investigator:	Alfonso Gúrpide, MD	Clínica Universitaria de Navarra
Principal Investigator:	Enrique Gonzalez, MD	Hospital General Universitario Morales Meseguer
Principal Investigator:	Guillermo López, MD	Hopspital de Cruces, Baracaldo (Vizcaya)
Principal Investigator:	César Rodríguez, MD	Hospital Clínico de Salamanca
Principal Investigator:	Juan C. Torrego, MD	Hospital del Río Hortega
Principal Investigator:	José Gómez, MD	HOSPITAL LA FE VALENCIA
Principal Investigator:	Albert Font, MD	Germans Trias i Pujol Hospital
Principal Investigator:	Isidoro C. Barneto, MD	Hospital Reina Sofia (Córdoba)
Principal Investigator:	Antonio Lorenzo, MD	Hospital de Puerto Real (Cádiz)
Principal Investigator:	Dolores Isla, MD	Hospital Clínico Lozano Blesa (Zaragoza)
Study Director:	Eduardo Rocha, MD	Clínica Universitaria de Navarra
Principal Investigator:	Bartolomeu Massuti, MD	Hospital General Universitario de Alicante
Principal Investigator:	Antonio Galán Brotons, MD	Hospital de Sagunto
Principal Investigator:	Ana Blasco Cordellat, MD	Hospital General Universitario de Valencia
Principal Investigator:	Juan J. Bretón, MD	Hospital Universitario Carlos Haya
Principal Investigator:	Isabel Bover Barceló, MD	Hospital Son Llàtzer
Principal Investigator:	Nuria Viñolas, MD	Hospital Clinic i Provincial de Barcelona

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lecumberri R, López Vivanco G, Font A, González Billalabeitia E, Gúrpide A, Gómez Codina J, Isla D, Galán 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.

Responsible Party:	Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:	NCT00324558 History of Changes
Other Study ID Numbers:	ICT-BEM-2004-01; 2004-004722-27 (Nº EudraCT)
First Posted:	May 11, 2006
Last Update Posted:	June 8, 2012
Last Verified:	June 2012

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:

Bemiparin; small cell lung carcinoma

Additional relevant MeSH terms:

Carcinoma; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms	Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Heparin, Low-Molecular-Weight; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action