Non-Small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer, chemotherapy, Low Molecular Weight Heparin
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.
Interventions
DRUGcisplatin + docetaxel
docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
DRUGcisplatin + 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
Sponsors
Universiteit Antwerpen
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | during chemotherapy and follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS) | during chemotherapy and follow-up |
| 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 |
Countries
Belgium
Outcome results
None listed