NCT00324558

Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Carcinoma, Small Cell

Interventions

Type	Name	Description
DRUG	Bemiparin	subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)

Timeline

• Start date: 2005-06-01
• Primary completion: 2010-02-01
• Completion: 2010-09-01
• First posted: 2006-05-11
• Last updated: 2012-06-08

Locations

15 sites across 1 country: Spain