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)

NCT00771563 | Completed Phase 3

• 2 other identifiers: TOGA 0601EudraCT 2007-007696-16
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; chemotherapy; Low Molecular Weight Heparin

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  during chemotherapy and follow-up

Secondary Outcomes (5)

• 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

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Chemotherapy without LMWH

Drug: cisplatin + docetaxel

Arm B

EXPERIMENTAL

Chemotherapy with LMWH

Drug: cisplatin + docetaxel + enoxaparin

Interventions

cisplatin + docetaxel DRUG

docetaxel 75 mg/m2 d1 and cisplatin 75mg/m2 d1 (q 3wks for 4 cycles)

Also known as: Platinol, Taxotere

Arm A

cisplatin + docetaxel + enoxaparin DRUG

cisplatin 75 mg/m2 d1 and docetaxel 75 mg/m2 d1 (q 3 wks for 4 cycles) + daily enoxaparin 1mg/kg/d sc

Also known as: Platinol, Taxotere, Clexane, LMWH

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (2)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman

Liège, Liège, 4000, Belgium

Location

Related Publications (1)

• Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

  PMID: 33337539 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Docetaxel; Enoxaparin; Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Paul R Germonpre, MD PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Thoracale Oncologie Groep Antwerpen

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

BE (2)