Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

NCT00324558 | Terminated Phase 2

• 2 other identifiers: ICT-BEM-2004-012004-004722-27 (Nº EudraCT)
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 15

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).

Conditions

Carcinoma, Small Cell

Keywords

Bemiparin; small cell lung carcinoma

Outcome Measures

Primary Outcomes (2)

• 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)

  efficacy

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

  safety

Study Arms (2)

1

EXPERIMENTAL

Bemiparin 3,500 IU

Drug: Bemiparin

Control

NO INTERVENTION

Interventions

Bemiparin DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (15)

Hospital General de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital Son Llàtzer

Son Ferriol, Balearic Islands, 07198, Spain

Location

Hospital Clinic i Provicial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Clínico Universitario de Puerto Real

Puerto Real, Cádiz, 11510, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Hospital Morales Meseguer

Murcia, Murcia, 30008, Spain

Location

Hospital Universitario Carlos Haya

Málaga, Málaga, 29010, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clínico de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Hospital de Sagunto

Port de Sagunt, Valencia, 46520, Spain

Location

Hospital La Fe

Valencia, Valencia, 46009, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Río Hortega

Valladolid, Valladolid, 47010, Spain

Location

Hospital de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (2)

• 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.

  PMID: 33337539 DERIVED

• 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.

  PMID: 24491267 DERIVED

MeSH Terms

Conditions

Carcinoma, Small Cell; Small Cell Lung Carcinoma

Interventions

bemiparin

Condition Hierarchy (Ancestors)

Carcinoma; 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

Study Officials

• 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 Rio Hortega

  PRINCIPAL INVESTIGATOR

• José Gómez, MD

  Hospital La Fe de 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)

  PRINCIPAL INVESTIGATOR

• Eduardo Rocha, MD

  Clínica Universitaria de Navarra

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: June 1, 2005
• Primary Completion: February 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 8, 2012

Record last verified: 2012-06

Locations

ES (15)