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)

Phase 3

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: cisplatin + docetaxel; Drug: cisplatin + docetaxel + enoxaparin

• Registration Number: NCT00771563
• Lead Sponsor: University Hospital, Antwerp

Brief 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.

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	cisplatin + docetaxel	Chemotherapy without LMWH
Arm B	cisplatin + docetaxel + enoxaparin	Chemotherapy with LMWH

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	during chemotherapy and follow-up

Secondary Outcome Measures

Name	Time	Method
Overall Survival	during chemotherapy and follow-up
Best Overall Response	during chemotherapy and follow-up
Incidence of total documented thromboembolic and hemorrhagic events	during chemotherapy and follow-up
Overall safety and tolerability	during chemotherapy and follow-up
Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS)	during chemotherapy and follow-up

Trial Locations

Locations (2)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium

Centre Hospitalier Universitaire Sart Tilman; 🇧🇪 Liège, Belgium