Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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.
Procedure: quality-of-life assessment
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70|
- Quality of life [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Mood status and autonomy of activity [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
- Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227708
|Centre Medico-Chirurgical de Creil|
|Creil, France, 60107|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Hospitalier Intercommunal St. Aubin les Elbeuf|
|Elbeuf, France, 76503|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Institut Curie Hopital|
|Paris, France, 75248|
|Clinique De Genolier|
|Genolier, Switzerland, Ch-1272|
|Charing Cross Hospital|
|London, England, United Kingdom, W6 8RF|
|Centre for Cancer Research and Cell Biology at Belfast City Hospital|
|Belfast, Northern Ireland, United Kingdom, BT9 7AB|
|West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||Pierre Fargeot, MD||Centre Georges Francois Leclerc|