Clinical trial NCT00324558: Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Carcinoma, Small Cell
Keywords: Bemiparin
small cell lung carcinoma
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2006-05-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
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)
timeFrame: efficacy
measure: safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings.
timeFrame: safety
Secondary outcomes:
Other outcomes:
Locations:
city: Puerto Real
country: Spain
facility: Hospital Clínico Universitario de Puerto Real
state: Cádiz
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
state: Córdoba
city: Son Ferriol
country: Spain
facility: Hospital Son Llàtzer
state: Islas Baleares
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Puerto de Sagunto
country: Spain
facility: Hospital de Sagunto
state: Valencia
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Clinic i Provicial de Barcelona
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Río Hortega
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
Study officials:
affiliation: Clínica Universitaria de Navarra
name: Alfonso Gúrpide, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario Morales Meseguer
name: Enrique Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopspital de Cruces, Baracaldo (Vizcaya)
name: Guillermo López, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico de Salamanca
name: César Rodríguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Rio Hortega
name: Juan C. Torrego, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL LA FE VALENCIA
name: José Gómez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Germans Trias i Pujol Hospital
name: Albert Font, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Reina Sofia (Córdoba)
name: Isidoro C. Barneto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Puerto Real (Cádiz)
name: Antonio Lorenzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Lozano Blesa (Zaragoza)
name: Dolores Isla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clínica Universitaria de Navarra
name: Eduardo Rocha, MD
role: STUDY_DIRECTOR
affiliation: Hospital General Universitario de Alicante
name: Bartolomeu Massuti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Sagunto
name: Antonio Galán Brotons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitario de Valencia
name: Ana Blasco Cordellat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Carlos Haya
name: Juan J. Bretón, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Llàtzer
name: Isabel Bover Barceló, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic i provincial de Barcelona
name: Nuria Viñolas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.