Randomised, open, multicenter, sequential trial assessing the safety and efficacy of bemiparin on the response to the treatment in patients diagnosed with localized small cell carcinoma of the lung. - ABEL STUDY

• Conditions: Small cell carcionoma of the lungmedDRA CLASSIFICATION CODE: PT 10041071; MedDRA version: 4.0Level: PTClassification code 10041071

• Registration Number: EUCTR2004-004722-27-ES
• Lead Sponsor: Instituto Científico y Tecnológico de Navarra, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients of both sexes, aged 18 or older, diagnosed with localized small cell carcinoma of the lung.

•Patients with an ECOG performance status <=2

•Patients who have given signed informed consent.

•Patients with a platelet count higher than 100.000 µl and without haemorrhagic symptomatology.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Curative or palliative surgery as a starting treatment of a neoplastic process.

•Patients with an active haemorrhage within the last two months, organic injuries susceptible to bleeding (ie.: active peptic ulcer, hemorrhagic CVA (Cerebrovascular Accident), aneurysm), antecedents of haemorrhagic episodes clinically significant, major surgery within the last month or increased bleeding risk due to any hemostasis disorders that may contraindicate anticoagulant therapy.

•Patients with hypersensitivity reactions to low molecular weight heparin (LMWH), heparin or substances of porcine origin.

•Patients with hipersensitivity reactions to carboplatin and cisplatin, or hipersensitivity reaction to etoposide.

•Patients with congenital or acquired bleeding diathesis.

•Possible hurts or surgical interventions located in the central nervous system, eyes and ears within 6 months prior to take part in the trial.

•Acute bacterial endocarditis and subacute endocarditis.

•Patients with thrombocytopenia related to heparin or with a current platelet cout <100.000 / mm3

•Patients with serious renal insufficiency, (creatinine >20 mmol/L and/or serum creatinine > 2mg/L) hepatic failure (with AST and/or ALT values 5 times higher than normal reference ranges).

•Non-controlled hypertension (PAS >200 mmHg; PAD >120 mmHg).

•Pregnant or lactation women, or women of childbearing potiential not practicing adequate means of contraception during the trial.

•Patients unlikely to comply with the protocol requirements

•Patients who take part in another clinical trial or did it within the last 30 days.

•Patients with life expectance less than 3 months.

•Patients who follow a treatment with any anticuagulant or did it within 3 months prior to the tumor diagnosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if the subcutaneous administration of bemiparin (3500 UI/day) for 26 weeks, administered at the start of the chemotherapy, contributes to slow down the tumoral progression and increases the progression-free survival.;Secondary Objective: To evaluate if the subcutaneous administration of bemiparin (3500 UI/day) for 26 weeks, administered at the start of the chemotherapy, increases the global survival, improves the response rate to the treatment with chemotherapy and radiotherapy and reduces the incidence of acute venous thromboembolism <br><br>;Primary end point(s): The primary efficacy endpoint for the evaluation of this trial is the progression free survival after 24 months follow-up.<br><br>The primary safety endpoint for the evaluation of this trial is the incidence, during the period of randomized treatment (since the last day of treatment + 7 days), of bleeding complications, characterised by major bleeding events (those that comply with the criteria described by EMEA).