Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

Carcinoma, Small Cell Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00324558
• Other study ID #: ICT-BEM-2004-01
• Secondary ID: 2004-004722-27 (
• Status: Terminated
• Phase: Phase 2
• First received: May 9, 2006
• Last updated: June 7, 2012
• Start date: June 2005
• Est. completion date: September 2010

Study information

• Verified date: June 2012
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: September 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients 18 years old or older, of either sex, with a diagnosis of limited small cell lung cancer.

2. Patients with an ECOG functional state less than or equal to 2.

3. Informed consent to participate in the study.

4. Patients with a platelet count above 100,000/microlitre with no hemorrhagic symptomatology.

Exclusion Criteria:

1. Curative or palliative surgery as the initial treatment of their neoplastic condition.

2. 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.

3. Known hypersensitivity to LMWH, heparin or substances of porcine origin.

4. 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.

5. Patients with congenital or acquired bleeding diathesis.

6. Damage to/ or surgical interventions of the central nervous system, eyes and ears within the past 6 months.

7. Acute bacterial endocarditis or slow endocarditis.

8. Patients with a history of heparin-associated thrombocytopenia or with a current platelet count < 100,000/mm3

9. 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).

10. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure above 120 mmHg).

11. Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.

12. Patients with suspected inability/or inability to comply with treatment and/or complete the study.

13. Patients who are participating in another clinical trial or have done so in the past 30 days.

14. Patients with a life expectancy less than 3 months.

15. Patients on treatment with anticoagulants or who have been on treatment during three months before the diagnosis of the tumor.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Small Cell
• Small Cell Lung Carcinoma

Intervention

Drug:
• Bemiparin
subcutaneous administration (sc) of Bemiparin (3,500 UI/day) for 26 weeks, starting on the first day of chemotherapy (CT)

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante
Spain	Hospital de Cruces	Barakaldo	Vizcaya
Spain	Hospital Clinic i Provicial de Barcelona	Barcelona
Spain	Hospital Universitario Reina Sofía	Cordoba	Córdoba
Spain	Hospital Universitario Carlos Haya	Málaga
Spain	Hospital Morales Meseguer	Murcia
Spain	Clinica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital de Sagunto	Puerto de Sagunto	Valencia
Spain	Hospital Clínico Universitario de Puerto Real	Puerto Real	Cádiz
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Hospital Son Llàtzer	Son Ferriol	Islas Baleares
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Río Hortega	Valladolid
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings.		safety	Yes