Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)
This study has been terminated.
(Sponsor stopped due to difficulties to recruit 130 patients required by protocol)
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT00324558
First received: May 9, 2006
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Carcinoma, Small Cell |
Drug: Bemiparin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:
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) [ Time Frame: efficacy ] [ Designated as safety issue: No ]
- safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. [ Time Frame: safety ] [ Designated as safety issue: Yes ]
| Enrollment: | 39 |
| Study Start Date: | June 2005 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
- Patients with a platelet count above 100,000/microlitre with no hemorrhagic symptomatology.
Exclusion Criteria:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324558
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324558
Locations
| Spain | |
| Hospital Clínico Universitario de Puerto Real | |
| Puerto Real, Cádiz, Spain, 11510 | |
| Hospital Universitario Reina Sofía | |
| Cordoba, Córdoba, Spain, 14004 | |
| Hospital Son Llàtzer | |
| Son Ferriol, Islas Baleares, Spain, 07198 | |
| Clinica Universitaria de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
| Hospital de Sagunto | |
| Puerto de Sagunto, Valencia, Spain, 46520 | |
| Hospital de Cruces | |
| Barakaldo, Vizcaya, Spain, 48903 | |
| Hospital General de Alicante | |
| Alicante, Spain, 03010 | |
| Hospital Clinic i Provicial de Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital Morales Meseguer | |
| Murcia, Spain, 30008 | |
| Hospital Universitario Carlos Haya | |
| Málaga, Spain, 29010 | |
| Hospital Clínico de Salamanca | |
| Salamanca, Spain, 37007 | |
| Hospital La Fe | |
| Valencia, Spain, 46009 | |
| Hospital General Universitario de Valencia | |
| Valencia, Spain, 46014 | |
| Hospital Río Hortega | |
| Valladolid, Spain, 47010 | |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Clinica Universidad de Navarra, Universidad de Navarra |
| ClinicalTrials.gov Identifier: | NCT00324558 History of Changes |
| Other Study ID Numbers: | ICT-BEM-2004-01 2004-004722-27 (Nº EudraCT) |
| Study First Received: | May 9, 2006 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
|
Bemiparin small cell lung carcinoma |
Additional relevant MeSH terms:
|
Carcinoma Small Cell Lung Carcinoma Carcinoma, Small Cell 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 Heparin, Low-Molecular-Weight Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2016