A Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer
Conditions
Small Cell Lung Cancer
Conditions: official terms
Lung Neoplasms - Small Cell Lung Carcinoma
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cisplatinum or carboplatin and e.g.etoposide. Type: Drug
Name: cisplatinum or carboplatin and e.g.etoposide+enoxaparin Type: Drug
Overall Status
Recruiting
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.
Detailed Description
Chemotherapy will be given in accordance with local or regional guidelines but shall include a platinum drug + any topoisomerase inhibitor. Within these limits the study will accept different local variants as long as each centre remains consistent to its declared standard chemotherapy regimen. The recommended regimen is carboplatin or cisplatin plus etoposide q3 weeks for 4 cycles but up to 6 cycles is allowed. Local dosages and dose reduction schedules will be used.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
Gävle hospital
Gävle, Sweden
Status: Recruiting
Contact: Hirsh Koyi, MD - hirsh.koyi@lg.se
Sahlgrenska University Hospital
Göteborg, Sweden
Status: Recruiting
Contact: Bengt Bergman, MD - bengt.bergman@lungall.gu.se
Helsingborg Hospital
Helsingborg, Sweden
Status: Recruiting
Contact: Mats Lagerstedt, MD - mats.lagerstedt@skane.se
Ryhov Hospital, Jönköping
Jönköping, Sweden
Status: Recruiting
Contact: Magnus Kentson, MD - magnus.kentson@lj.se
Blekinge Hospital
Karlskrona, Sweden
Status: Recruiting
Contact: Bengt Dahlander, MD - bengt.dahlander@ltblekinge.se
Central Hospital
Karlstad, Sweden
Status: Recruiting
Contact: Martin Rydin, MD - martin.rydin@liv.se
Central Hospital
Kristianstad, Sweden
Status: Recruiting
Contact: Inga Svensson, MD - inga.n.svensson@skane.se
University Hospital Linköping
Linköping, Sweden
Status: Recruiting
Contact: Christer Cederholm, MD - christer.cederholm@lio.se
University Hospital Department of Respiratory Medicine
Lund, Sweden
Status: Recruiting
Contact: Lars Ek, MD - +46 46 17 7340 - lars.ek@skane.se
University Hospital MAS
Malmö, Sweden
Status: Recruiting
Contact: Jaroslaw Kosieradzki, MD - jaroslaw.kosieradzki@skane.se
Karolinska University Hospital
Stockholm, Sweden
Status: Recruiting
Contact: Karl-Gustav Kölbeck, MD - karl.kolbeck@karolinska.se
Norrlands University Hospital
Umeå, Sweden
Status: Recruiting
Contact: Annelie Behndig, MD - annelie.behndig@lung.umu.se
Akademiska hospital Uppsala
Uppsala, Sweden
Status: Recruiting
Contact: Kristina Lamberg, MD - kristina.lamberg@akademiska.se
Central Hospital
Växjö, Sweden
Status: Recruiting
Contact: Gunilla Lindström, MD - gunilla.lindstrom@ltkronoberg.se
Ystad hospital
Ystad, Sweden
Status: Recruiting
Contact: Kerstin Andersson, MD - kerstin.e.andersson@skane.se
University Hospital, Örebro
Örebro, Sweden
Status: Recruiting
Contact: Lars Thaning, MD - lars.thaning@orebroll.se
Start Date
June 2008
Completion Date
December 2016
Sponsors
Lund University Hospital
Source
Lund University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page