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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-GERCOR-DOCEGEM-B00-2 | |||
| EU-20331 |
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months thereafter.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | |||
| gemcitabine hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | ||
| Overall survival | ||
| Tolerability |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes:
Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease
Inoperable disease
Measurable disease
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Terrioux, MD | Clinique de Docteur Terrioux |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Avicenne | Bobigny | 93009 | France | |||
| Centre Jean Bernard |
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| Quality of life |
| Le Mans |
| 72000 |
| France |
| Hopital Perpetuel Secours | Levallois-Perret | 92300 | France |
| Centre de Radiotherapie et Oncologie Saint-Faron | Mareuil-lès-Meaux | 77100 | France |
| Clinique de Docteur Terrioux | Meaux | 77100 | France |
| American Hospital of Paris | Neuilly-sur-Seine | F-92202 | France |
| Hopital Tenon | Paris | 75970 | France |
| Clinique les Bleuets | Reims | 51100 | France |
| Polyclinique De Courlancy | Reims | F-51100 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| Clinique Francois | Saint-Dizier | 52100 | France |
| Hopital Paul Brousse | Villejuif | 94804 | France |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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