Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00227708|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : August 20, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: docetaxel Procedure: quality-of-life assessment||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2005|
- Quality of life
- Response rate
- Overall survival
- Progression-free survival
- Mood status and autonomy of activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|