E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Small cell carcionoma of the lung medDRA CLASSIFICATION CODE: PT 10041071
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 4.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041071 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |