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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT00771563
First received: October 10, 2008
Last updated: January 16, 2012
Last verified: January 2012
History of Changes

October 10, 2008
January 16, 2012
June 2008
June 2013   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00771563 on ClinicalTrials.gov Archive Site
  • Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS) [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
  • Best Overall Response [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]
  • Incidence of total documented thromboembolic and hemorrhagic events [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: Yes ]
  • Overall safety and tolerability [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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)
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: cisplatin + docetaxel
    docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
    Other Names:
    • Platinol
    • Taxotere
  • Drug: 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
    Other Names:
    • Platinol
    • Taxotere
    • Clexane
    • LMWH
  • Active Comparator: Arm A
    Chemotherapy without LMWH
    Intervention: Drug: cisplatin + docetaxel
  • Experimental: Arm B
    Chemotherapy with LMWH
    Intervention: Drug: cisplatin + docetaxel + enoxaparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
360
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00771563
TOGA 0601, EudraCT 2007-007696-16
No
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
University Hospital, Antwerp
Universiteit Antwerpen
Principal Investigator: Paul R Germonpre, MD PhD Universiteit Antwerpen
University Hospital, Antwerp
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP