Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00227708
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in older patients.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel.
Secondary
* Determine the response rate in patients treated with this drug.
* Determine the overall survival and progression-free survival of patients treated with this drug.
* Determine the mood status and autonomy of activity of patients treated with this drug.
* Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV twice in week 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed during study therapy in weeks 3-4, 7-8, and 11-12, and then at 6 and 12 months after completion of study treatment.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality of life
- Secondary Outcome Measures
Name Time Method Response rate Overall survival Toxicity Progression-free survival Mood status and autonomy of activity
Trial Locations
- Locations (9)
Clinique De Genolier
🇨ðŸ‡Genolier, Switzerland
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
🇫🇷Elbeuf, France
Charing Cross Hospital
🇬🇧London, England, United Kingdom
West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Centre Medico-Chirurgical de Creil
🇫🇷Creil, France
Institut Curie Hopital
🇫🇷Paris, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre for Cancer Research and Cell Biology at Belfast City Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom