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

Sponsors and Collaborators:	Lund University Hospital Sanofi-Aventis
Information provided by:	Lund University Hospital
ClinicalTrials.gov Identifier:	NCT00717938

Purpose

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.

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: cisplatinum or carboplatin and e.g.etoposide. Drug: cisplatinum or carboplatin and e.g.etoposide+enoxaparin	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Etoposide Cisplatin Etoposide phosphate Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase III Study of Standard Treatment +/- Enoxaparin in Small Cell Lung Cancer

Further study details as provided by Lund University Hospital:

Primary Outcome Measures:

Significant increase of overall survival [ Time Frame: At follow up 1 year after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Toxicity [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	390
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants.Used drugs=cisplatinum or carboplatin and e.g.etoposide.	Drug: cisplatinum or carboplatin and e.g.etoposide. Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. Used drugs=cisplatinum or carboplatin and e.g.etoposide. Treatment will be given every three weeks for 4-6 cycles according to local variants.
B: Experimental Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. Used drugs=cisplatinum or carboplatin and e.g.etoposide. In addition to this, subjects will receive daily subcutaneous injections of enoxaparin during chemotherapy treatment.	Drug: cisplatinum or carboplatin and e.g.etoposide+enoxaparin Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Numbers of cycles 4-6 according to local variants. In addition to this, subjects will receive daily subcutaneous injections of enoxaparin during chemotherapy treatment.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically verified SCLC, all stages
WHO performance status 0, 1, 2 or 3
Age 18 years or older
Intention and feasibility to treat with chemotherapy consisting of platinum + topoisomerase inhibitor.
Platelets >100 x109 /L
Signed informed consent
PK (prothrombin complex) INR and APTT within normal ranges.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717938

Contacts

Contact: Lars Ek, MD	+46 46 17 73 40	lars.ek@skane.se
Contact: Jan Sundberg, RN	+46 46 17 70 34	jan.sundberg@skane.se

Locations

Sweden
University Hospital Department of Respiratory Medicine	Recruiting
Lund, Sweden, 221 85
Contact: Martin Wallberg, MD +46 46 17 14 56 martin.wallberg@med.lu.se
Contact: Jan Sundberg, RN +46 46 17 70 34 jan.sundberg@skane.se
Principal Investigator: Lars EK, MD

Sponsors and Collaborators

Lund University Hospital

Sanofi-Aventis

Investigators

Principal Investigator:	Lars Ek, MD	University Hospital, Lund
Study Director:	Jan Sundberg, RN	University Hospital, Lund

More Information

Responsible Party:	University Hospital Lund, Department of Respiratory Medicine ( Lars Ek )
Study ID Numbers:	EudraCT number 2007-006033-14
Study First Received:	July 16, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00717938
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carboplatin
Etoposide phosphate
Enoxaparin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors

Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents

Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009