Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Bemiparin 3,500 IU |
Drug: Bemiparin
subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)
|
| No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
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Patients with a platelet count above 100,000/microlitre with no hemorrhagic symptomatology.
Exclusion Criteria:
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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.
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Known hypersensitivity to LMWH, heparin or substances of porcine origin.
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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.
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Patients with congenital or acquired bleeding diathesis.
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Damage to/ or surgical interventions of the central nervous system, eyes and ears within the past 6 months.
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Acute bacterial endocarditis or slow endocarditis.
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Patients with a history of heparin-associated thrombocytopenia or with a current platelet count < 100,000/mm3
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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).
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Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure above 120 mmHg).
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Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
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Patients with suspected inability/or inability to comply with treatment and/or complete the study.
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Patients who are participating in another clinical trial or have done so in the past 30 days.
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Patients with a life expectancy less than 3 months.
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Patients on treatment with anticoagulants or who have been on treatment during three months before the diagnosis of the tumor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínico Universitario de Puerto Real | Puerto Real | Cádiz | Spain | 11510 |
| 2 | Hospital Universitario Reina Sofía | Cordoba | Córdoba | Spain | 14004 |
| 3 | Hospital Son Llàtzer | Son Ferriol | Islas Baleares | Spain | 07198 |
| 4 | Clinica Universitaria de Navarra | Pamplona | Navarra | Spain | 31008 |
| 5 | Hospital de Sagunto | Puerto de Sagunto | Valencia | Spain | 46520 |
| 6 | Hospital de Cruces | Barakaldo | Vizcaya | Spain | 48903 |
| 7 | Hospital General de Alicante | Alicante | Spain | 03010 | |
| 8 | Hospital Clinic i Provicial de Barcelona | Barcelona | Spain | 08036 | |
| 9 | Hospital Morales Meseguer | Murcia | Spain | 30008 | |
| 10 | Hospital Universitario Carlos Haya | Málaga | Spain | 29010 | |
| 11 | Hospital Clínico de Salamanca | Salamanca | Spain | 37007 | |
| 12 | Hospital La Fe | Valencia | Spain | 46009 | |
| 13 | Hospital General Universitario de Valencia | Valencia | Spain | 46014 | |
| 14 | Hospital Río Hortega | Valladolid | Spain | 47010 | |
| 15 | Hospital Clínico Lozano Blesa | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra
Investigators
- Principal Investigator: 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 Río Hortega
- Principal Investigator: José Gómez, MD, HOSPITAL LA FE 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)
- Study Director: Eduardo Rocha, MD, Clínica Universitaria de Navarra
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICT-BEM-2004-01
- 2004-004722-27 (Nº EudraCT)