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)

Antwerp University Hospital (UZA)

Status and phase

Completed

Phase 3

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: cisplatin + docetaxel

Drug: cisplatin + docetaxel + enoxaparin

Study type

Interventional

Funder types

Other

Identifiers

NCT00771563

EudraCT 2007-007696-16

TOGA 0601

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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