A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The endpoint is to investigate if the addition of low molecular heparin - enoxaparin, will result in a significant increase of overall survival in patients with small cell lung cancer, receiving standard chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Collaborator: Sanofi
• Treatments: Carboplatin; Cisplatin; Enoxaparin; Enoxaparin sodium; Etoposide; Etoposide phosphate; Topoisomerase Inhibitors

Criteria

Inclusion Criteria:

1. Histologically or cytologically verified SCLC, all stages

2. WHO performance status 0, 1, 2 or 3

3. Age 18 years or older

4. Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor.

5. Platelets >100 x109 /L

6. Signed informed consent

7. PK (prothrombin complex) INR and APTT within normal ranges.

Exclusion Criteria:

1. Prior systemic chemotherapy for lung cancer.

2. Concomitant anticoagulation treatment, except for ASA or clopidogrel

3. Active overt bleeding of clinical importance or at high risk (e.g. earlier observed haemorrhage in a brain metastasis, severe coagulopathy as haemophilia, severe liver dysfunction with impaired coagulation, acute peptic ulcer, and within the last 3 months suffered from intracranial haemorrhage, or surgery in the central nervous system).

4. Any other known contraindication for enoxaparine ( e.g. Hypersensitivity against enoxaparine and its derivatives).

5. Pregnancy or breast-feeding

6. Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period.

7. Treatment with any other investigational agent, or participation in any other clinical trial.