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)

Non-Small Cell Lung Cancer Clinical Trial

— SYRINGES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771563
• Other study ID #: TOGA 0601
• Secondary ID: EudraCT 2007-007
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2008
• Last updated: June 27, 2013
• Start date: June 2008
• Est. completion date: October 2012

Study information

• Verified date: June 2013
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• cisplatin + docetaxel
docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
• 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

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp
Belgium	Centre Hospitalier Universitaire Sart Tilman	Liège

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		during chemotherapy and follow-up	No
Secondary	Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS)		during chemotherapy and follow-up	No
Secondary	Overall Survival		during chemotherapy and follow-up	No
Secondary	Best Overall Response		during chemotherapy and follow-up	No
Secondary	Incidence of total documented thromboembolic and hemorrhagic events		during chemotherapy and follow-up	Yes
Secondary	Overall safety and tolerability		during chemotherapy and follow-up	Yes