Randomised Study Comparing Three Chemotherapy Regimens in Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	European Lung Cancer Working Party
Information provided by:	European Lung Cancer Working Party
ClinicalTrials.gov Identifier:	NCT00622349

Purpose

The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Cisplatin, Ifosfamide, Gemcitabine Drug: Ifosfamide, Gemcitabine Drug: Cisplatin, docetaxel	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Mesna Ifosfamide Docetaxel Cisplatin Gemcitabine hydrochloride Gemcitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-Treated Advanced Non-Small Cell Lung Cancer

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

Primary Outcome Measures:

Survival [ Time Frame: Survival will be dated from the first day of registration until death or last follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response rate [ Time Frame: Every 3 courses of chemotherapy ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: After each course of chemotherapy ] [ Designated as safety issue: No ]
Activity of second-line chemotherapy [ Time Frame: Every 3 courses of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	620
Study Start Date:	February 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Cisplatin, Ifosfamide, Gemcitabine Cisplatin 50 mg/m² day 1 Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
B: Active Comparator	Drug: Ifosfamide, Gemcitabine Ifosfamide 3g/m² day 1 (+ uromitexan rescue) Gemcitabine 1 g/m² days 1 and 8 Cycles every 3 weeks
C: Experimental	Drug: Cisplatin, docetaxel Cisplatin 50 mg/m² day 1 Docetaxel 75 mg/m² day 1 Cycles 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 non-small cell lung cancer
Advanced (unresectable or functionally inoperable) stage III or stage IV disease
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
Operable patient with resectable tumour
Performance status < 60 on the Karnofsky scale
A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
Polynuclear cells < 2,000/mm³
Platelet cells < 100,000/mm³
Serum bilirubin >1.5 mg/100 ml
Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
Perception hypoacousia
Peripheral neuropathy
Recent myocardial infarction (less than 3 months prior to date of diagnosis)
Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia
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: NCT00622349

Contacts

Contact: Nathalie Leclercq, RN	0032/2/5390496	nathalie.leclercq@bordet.be
Contact: Thierry Berghmans, MD	0032/2/5390496

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
Pneumology department of CHU Lille	Recruiting
Lille, France
Principal Investigator: Jean-Jacques Lafitte, 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

Click here for more information on the protocol This link exits the ClinicalTrials.gov site

Trial registry of the French National Cancer Institute This link exits the ClinicalTrials.gov site

Responsible Party:	European Lung Cancer Working Party ( Dr Berghmans Thierry )
Study ID Numbers:	ELCWP-01041
Study First Received:	February 14, 2008
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00622349
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency

Keywords provided by European Lung Cancer Working Party:

Randomised phase III
Chemotherapy
Advanced non-small cell lung carcinoma

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Carcinoma
Docetaxel
Ifosfamide
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Mechlorethamine
Lung Diseases
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Mesna
Neoplasms, Glandular and Epithelial
Isophosphamide mustard

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009