Enoxaparin Low Molecular Weight Heparin (LMWH) in Advanced Non Small Cell Lung Cancer: Effect on Survival and Symptom Control in Patients Undergoing First Line Chemotherapy (SYRINGES) - Full Text View

Sponsors and Collaborators:	University Hospital, Antwerp Universiteit Antwerpen
Information provided by:	University Hospital, Antwerp
ClinicalTrials.gov Identifier:	NCT00771563

Purpose

Rationale: a number of recent phase III randomized trials have shown a survival benefit of a treatment with subcutaneous low-molecular weight heparin in patients with advanced solid malignancies. The survival advantages observed in the studies persist for months after the active treatment with LMWHs. Therefore these survival advantages are thought to be due to effects of LMWHs on tumor cell biology.

First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination has been widely studied, and is amongst the most active treatments currently available. The occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range, making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced NSCLC.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: cisplatin + docetaxel Drug: cisplatin + docetaxel + enoxaparin	Phase III

MedlinePlus related topics: Blood Thinners Cancer Lung Cancer

Drug Information available for: Docetaxel Cisplatin Heparin Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Low Molecular Weight Heparin in Advanced Non Small Cell Lung Cancer (NSCLC): a Randomized Open Label Phase III Study Evaluating the Effect of Enoxaparin (Clexane) on Survival and Symptom Control in Patients With Stage IIIB and IV NSCLC Undergoing a Cisplatin Based First Line Chemotherapy: the SYRINGES Trial

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:

Progression Free Survival [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS) [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
Best Overall Response [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
Incidence of total documented thromboembolic and hemorrhagic events [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: Yes ]
Overall safety and tolerability [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	360
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm A: Active Comparator Chemotherapy without LMWH	Drug: cisplatin + docetaxel docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
Arm B: Experimental Chemotherapy with LMWH	Drug: cisplatin + docetaxel + enoxaparin cisplatin 75 mg/m2 d1 and docetaxel 75 mg/m2 d1 (q 3 wks for 4 cycles) + daily enoxaparin 1mg/kg/d sc

Detailed Description:

Purpose: the aim of this study is to evaluate the potential beneficial antitumoral effect of LMWH enoxaparin in patients with locally advanced or metastatic NSCLC determined by the time to progression, the overall survival and the symptom control. LMWH will be added to a first line cisplatin-based chemotherapy.

Eligibility

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

Criteria

Inclusion Criteria:

Locally advanced or metastatic NSCLC (stage IIIB or IV)
Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy
At least one measurable lesion according to RECIST criteria
Good performance status
Adequate haematological, renal and liver function
Written informed consent

Exclusion Criteria:

Previous chemotherapy for NSCLC
Brain metastasis
History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
Concomitant therapy with an anti-angiogenesis agent
Contra-indication for LMWH
Life expectancy of < 3 months
Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771563

Contacts

Contact: Paul R Germonpre, MD PhD

++32 3 821 34 47

paul.germonpre@ua.ac.be

Locations

Belgium
Centre Hospitalier Universitaire Sart Tilman	Recruiting
Liège, Belgium, 4000
Contact: Leon Bosquee, MD
Principal Investigator: Leon Bsoquee, MD
Belgium, Antwerp
University Hospital Antwerp	Enrolling by invitation
Edegem, Antwerp, Belgium, 2650

Sponsors and Collaborators

University Hospital, Antwerp

Universiteit Antwerpen

Investigators

Principal Investigator:

Paul R Germonpre, MD PhD

Universiteit Antwerpen

More Information

Responsible Party:	University Antwerp ( Prof Dr Paul Germonpré )
Study ID Numbers:	TOGA 0601, EudraCT 2007-007696-16
Study First Received:	October 10, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00771563
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:

Non-Small Cell Lung Cancer
chemotherapy
Low Molecular Weight Heparin

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Heparin, Low-Molecular-Weight
Enoxaparin
Carcinoma
Calcium heparin
Body Weight
Docetaxel

Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Heparin
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on January 16, 2009