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:
European Lung Cancer Working Party
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
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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:
Drug Information available for:
Ifosfamide
Cisplatin
Etoposide
Epirubicin hydrochloride
Epirubicin
Etoposide phosphate
U.S. FDA Resources
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 June 18, 2013