Patients with small cell lung cancer, who are going to receive chemotherapy treatment with a platinum- and topoisomeras inhibitor containing regimen. MedDRA version: 14.1 Level: LLT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Klexane
Product Name: Klexane
Product Code: Not applicable
Pharmaceutical Form: Injection
INN or Proposed INN: ENOXAPARIN SODIUM
CAS Number: 01/08/9041
Current Sponsor code: NA
Other descr
Sponsors
University Hospital Lund, Thoracic Oncology Unit, Dept of Respiratory Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically verified small cell lung cancer, all stages WHO Performance Status 0-3 Age 18 years or older Intention and feasibility to treat with chemotherapy consisting of a platinum and a topoisomeras inhibitor Platelets over 100 x 10 9/L PK (prothrombine komplex) INR and APTT within normal ranges Signed informed concent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 290
Exclusion criteria
Exclusion criteria: Prior systemic chemotherapy for lung cancer Concomitant anticoagulation treatment, except for ASA or clopidogrel Active overt bleeding of clinical importance or at high risk Any other known contraindication for enoxaparine (eg. hypersensitivity against enoxaparine and its derivates Pregnancy or breast feeding Fertile women not using effective contraceptives or men who do not agree to use effective contraception during the treatment period Treatment with any other investigational agent, or participation in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective with the study is to evaluate treatment with chemotherapy with a platinum- and a topoisomeras inhibitor containing regimen versus treatment with the same chemotherapy with addition of enoxaparin comparing overall survival.;Secondary Objective: Second objectives are: To evaluate toxicity To evaluate clinically significant haemorrhagia To evaluate progression free survival To evaluate thromboembolic events To perform translational research;Primary end point(s): To demonstrate that addition of enoxaparine to standard chemotherapy treatment containing a platinum- and a topoisomeras inhibitor drug results in a significant increase in overall survival.;Timepoint(s) of evaluation of this end point: During study treatment, at follow up 2 and 12 months after end of treatment, and then untill patients death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Toxicity Clinically significant hemorrhage Progression free survival Thromboembolic events Relation between different serum- and tumour markers and prognosis with or without enoxaparin;Timepoint(s) of evaluation of this end point: During study treatment, at follow up 2 and 12 months after end of treatment. | — |
Countries
Denmark, Sweden
Contacts
Public ContactLars Ek
Lund University Hospital
Outcome results
None listed