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

Information source: Lund University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Cancer

Intervention: cisplatinum or carboplatin and e.g.etoposide. (Drug); cisplatinum or carboplatin and e.g.etoposide+enoxaparin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Lund University Hospital

Official(s) and/or principal investigator(s):
Lars Ek, MD, Principal Investigator, Affiliation: University Hospital, Lund
Jan Sundberg, RN, Study Director, Affiliation: University Hospital, Lund

Overall contact:
Lars Ek, MD, Phone: +46 46 17 73 40, Email: lars.ek@skane.se

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.

Clinical Details

Official title: A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

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

Primary outcome: Significant increase of overall survival

Secondary outcome: Toxicity

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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 and Contacts

Lars Ek, MD, Phone: +46 46 17 73 40, Email: lars.ek@skane.se

Gävle hospital, Gävle 801 87, Sweden; Recruiting
Hirsh Koyi, MD, Email: hirsh.koyi@lg.se
Hirsh Koyi, MD, Principal Investigator

Sahlgrenska University Hospital, Göteborg 413 45, Sweden; Recruiting
Bengt Bergman, MD, Email: bengt.bergman@lungall.gu.se
Bengt Bergman, MD, Principal Investigator

Helsingborg Hospital, Helsingborg, Sweden; Recruiting
Mats Lagerstedt, MD, Email: mats.lagerstedt@skane.se
Mats Lagerstedt, MD, Principal Investigator

Ryhov Hospital, Jönköping, Jönköping, Sweden; Recruiting
Magnus Kentson, MD, Email: magnus.kentson@lj.se
Magnus Kentson, MD, Principal Investigator

Blekinge Hospital, Karlskrona 371 85, Sweden; Recruiting
Bengt Dahlander, MD, Email: bengt.dahlander@ltblekinge.se
Bengt Dahlander, MD, Principal Investigator

Central Hospital, Karlstad 651 85, Sweden; Recruiting
Martin Rydin, MD, Email: martin.rydin@liv.se
Martin Rydin, MD, Principal Investigator

Central Hospital, Kristianstad 291 85, Sweden; Recruiting
Inga Svensson, MD, Email: inga.n.svensson@skane.se
Inga Svensson, MD, Principal Investigator

University Hospital Linköping, Linköping 581 85, Sweden; Recruiting
Christer Cederholm, MD, Email: christer.cederholm@lio.se
Christer Cederholm, MD, Principal Investigator

University Hospital Department of Respiratory Medicine, Lund 221 85, Sweden; Recruiting
Lars Ek, MD, Phone: +46 46 17 7340, Email: lars.ek@skane.se
Jan Sundberg, RN, Phone: +46 46 17 70 34, Email: jan.sundberg@skane.se
Lars EK, MD, Principal Investigator

University Hospital MAS, Malmö 205 02, Sweden; Recruiting
Jaroslaw Kosieradzki, MD, Email: jaroslaw.kosieradzki@skane.se
Jaroslaw Kosieradzki, MD, Principal Investigator

Karolinska University Hospital, Stockholm 171 76, Sweden; Recruiting
Karl-Gustav Kölbeck, MD, Email: karl.kolbeck@karolinska.se
Karl-Gustav Kölbeck, MD, Principal Investigator

Norrlands University Hospital, Umeå, Sweden; Recruiting
Annelie Behndig, MD, Email: annelie.behndig@lung.umu.se
Annelie Behndig, MD, Principal Investigator

Akademiska hospital Uppsala, Uppsala 751 85, Sweden; Recruiting
Kristina Lamberg, MD, Email: kristina.lamberg@akademiska.se
Kristina Lamberg, MD, Principal Investigator

Central Hospital, Växjö 351 85, Sweden; Recruiting
Gunilla Lindström, MD, Email: gunilla.lindstrom@ltkronoberg.se
Gunilla Lindström, MD, Principal Investigator

Ystad hospital, Ystad 271 82, Sweden; Recruiting
Kerstin Andersson, MD, Email: kerstin.e.andersson@skane.se
Kerstin Andersson, MD, Principal Investigator

University Hospital, Örebro, Örebro, Sweden; Recruiting
Lars Thaning, MD, Email: lars.thaning@orebroll.se
Lars Thaning, MD, Principal Investigator

Additional Information

Starting date: June 2008
Last updated: April 10, 2015

Page last updated: August 20, 2015

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