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 has been completed.
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: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: cisplatin + docetaxel
Drug: cisplatin + docetaxel + enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: during chemotherapy and follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 104
Study Start Date: June 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Chemotherapy without LMWH
Drug: cisplatin + docetaxel
docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)
Other Names:
  • Platinol
  • Taxotere
Experimental: Arm B
Chemotherapy with LMWH
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771563

Locations
Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Centre Hospitalier Universitaire Sart Tilman
Liège, Belgium, 4000
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Investigators
Principal Investigator: Paul R Germonpre, MD PhD Universiteit Antwerpen
  More Information

No publications provided

Responsible Party: Ethisch Comité UZ Antwerpen, Thoracale Oncologie Groep Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT00771563     History of Changes
Other Study ID Numbers: TOGA 0601, EudraCT 2007-007696-16
Study First Received: October 10, 2008
Last Updated: June 27, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
Non-Small Cell Lung Cancer
chemotherapy
Low Molecular Weight Heparin

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 01, 2014