Randomized Study of Cisplatin-Etoposide Versus an Etoposide Regimen Without Cisplatin in Extensive Small-Cell Lung Cancer

This study is currently recruiting participants.
Verified January 2013 by European Lung Cancer Working Party
Sponsor:
Information provided by:
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT00658580
First received: April 11, 2008
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine if a cisplatin-etoposide regimen improves survival in comparison to a regimen containing etoposide and without platinum derivative.


Condition Intervention Phase
Small Cell Lung Carcinoma, Extensive Disease
Drug: Cisplatin + etoposide
Drug: Epirubicin + ifosfamide + etoposide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study Comparing A Chemotherapy With Cisplatin And Etoposide To A Etoposide Regimen Without Cisplatin For Patients With Extensive Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:
  • Survival [ Time Frame: Survival will be dated from the day of randomisation until death or last follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: Every 3 cycles of chemotherapy ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: After every cycle of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: April 2000
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Every 3 weeks intravenous cisplatin plus etoposide
Drug: Cisplatin + etoposide

Cisplatin 90 mg/m² day 1, every 3 weeks

Etoposide 100 mg/m² days 1-3, every 3 weeks

Experimental: B
Every 3 weeks intravenous epirubicin plus ifosfamide plus etoposide
Drug: Epirubicin + ifosfamide + etoposide

Epirubicin 60 mg/m² day 1, every 3 weeks

Ifosfamide (+ uromitexan) 1.5 g/m² days 1-3, every 3 weeks

Etoposide 100 mg/m² days 1-3, every 3 weeks


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological diagnosis of small-cell lung cancer
  • Extensive disease (i.e. a disease with distant metastases or that cannot be included in a single irradiation field incorporating primary tumour, mediastinum and supraclavicular lymph node(s))
  • Availability for participating in the detailed follow-up of the protocol
  • Presence of an evaluable or measurable lesion
  • Informed consent

Exclusion Criteria:

  • Prior treatment with chemotherapy, radiotherapy or surgery
  • Performance status < 60 on the Karnofsky scale
  • A history of prior malignant tumor, except non-melanoma skin cancer or in situ carcinoma of the cervix or a cured cancer (defined as a disease-free interval > 5 years)
  • White blood cells < 4000/mm3
  • Platelets < 100000/mm3
  • Serum bilirubin > 1.5 mg/100 ml
  • Serum creatinine > 1.3 mg/100 ml and creatinine clearance <60 ml/min
  • Recent myocardial infarction (less than 3 months prior to date of diagnosis)
  • Congestive cardiac failure or cardiac arrhythmia uncontrolled by medical treatment
  • Uncontrolled infectious disease
  • Serious medical or psychological factors which may prevent adherence to the treatment schedule
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658580

Contacts
Contact: Nathalie Leclercq, RN 32-2-539-0496 nathalie.leclercq@bordet.be
Contact: Thierry Berghmans, MD 32-2-541-3111

Locations
Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Principal Investigator: Jean-Paul Sculier, MD, PhD         
France
Department of Pneumology CHRU Lille Recruiting
Lille, France
Contact: Arnaud Scherpereel, MD, PhD    33-32-044-4998      
Principal Investigator: Arnaud Scherpereel, MD, PhD         
Greece
Hellenic Cancer Institute - St Savas Oncology Hospital Recruiting
Athens, Greece
Principal Investigator: Anna Efremidis, MD         
Spain
Medical Oncology Hospital de Sagunto Recruiting
Valencia, Spain
Principal Investigator: Vicente Giner, MD         
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
Study Chair: Jean-Paul Sculier, MD, PhD European Lung Cancer Working Party
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Thierry Berghmans, European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00658580     History of Changes
Other Study ID Numbers: ELCWP 01994
Study First Received: April 11, 2008
Last Updated: January 28, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: Ethics Committee
Spain: Ethics Committee

Keywords provided by European Lung Cancer Working Party:
Small cell lung carcinoma
Chemotherapy
Phase III randomised study

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Isophosphamide mustard
Cisplatin
Epirubicin
Etoposide
Ifosfamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014