Small cell carcionoma of the lung medDRA CLASSIFICATION CODE: PT 10041071 MedDRA version: 4.0 Level: PT Classification code 10041071
Conditions
Interventions
Trade Name: HIBOR®/IVOR®
Product Name: HIBOR® /IVOR®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BEMIPARIN SODIUM
Concentration unit: IU/ml international unit(s)/millilitre
Conc
Sponsors
Instituto Científico y Tecnológico de Navarra, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;Primary end point(s): The primary efficacy endpoint for the evaluation of this trial is the progression free survival after 24 months follow-up. 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). | — |
Countries
Spain
Outcome results
None listed