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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-GERICO-05/0501 | |||
| EU-20521 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | |||
| quality-of-life assessment | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | ||
| Overall survival | ||
| Progression-free survival |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combination of these histologies
Measurable disease by CT scan or MRI
No symptomatic brain metastasis
Activity of Daily Living Scale score ≥ 4
Instrumental Autonomy of Daily Living Scale score ≥ 4
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Neurologic
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Fargeot, MD | Centre Georges Francois Leclerc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Medico-Chirurgical de Creil | Creil | 60107 | France | |||
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Mood status and autonomy of activity |
| Toxicity |
| Dijon |
| 21079 |
| France |
| Centre Hospitalier Intercommunal St. Aubin les Elbeuf | Elbeuf | 76503 | France |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| Institut Curie Hopital | Paris | 75248 | France |
| Clinique De Genolier | Genolier | Ch-1272 | Switzerland |
| Charing Cross Hospital | London | England | W6 8RF | United Kingdom |
| Centre for Cancer Research and Cell Biology at Belfast City Hospital | Belfast | Northern Ireland | BT9 7AB | United Kingdom |
| West of Scotland Cancer Centre | Glasgow | Scotland | G11 6NT | United Kingdom |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |