Adjuvant BEmiparin in Small Cell Lung Carcinoma (ABEL STUDY)

• Status: Terminated
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Treatments: Bemiparin; Heparin, Low-Molecular-Weight

Criteria

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.