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)

Condition(s) targeted: Non-small Cell Lung Cancer

Intervention: cisplatin + docetaxel (Drug); cisplatin + docetaxel + enoxaparin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University Hospital, Antwerp

Official(s) and/or principal investigator(s):
Paul R Germonpre, MD PhD, Principal Investigator, Affiliation: Universiteit Antwerpen

Overall contact:
Paul R Germonpre, MD PhD, Phone: ++32 3 821 34 47, Email: paul.germonpre@ua.ac.be

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.

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

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

Primary outcome: Progression Free Survival

Secondary outcome:

Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS)

Overall Survival

Best Overall Response

Incidence of total documented thromboembolic and hemorrhagic events

Overall safety and tolerability

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Paul R Germonpre, MD PhD, Phone: ++32 3 821 34 47, Email: paul.germonpre@ua.ac.be

Centre Hospitalier Universitaire Sart Tilman, Liège 4000, Belgium; Recruiting
Leon Bosquee, MD
Leon Bsoquee, MD, Principal Investigator

University Hospital Antwerp, Edegem, Antwerp 2650, Belgium; Recruiting
Paul R Germonpre, MD PhD, Phone: ++ 32 3 821 34 47, Email: paul.germonpre@ua.ac.be
Paul R Germonpre, MD PhD, Principal Investigator

Starting date: June 2008
Last updated: December 14, 2010