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| ID | Type | Description | Link |
|---|---|---|---|
| YONSEI-4-2008-0132 | |||
| SANOFI-AVENTIS-YONSEI-4-2008-0 |
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is comparing different combination chemotherapy regimens to see how well they work as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
RNA is isolated from pretreatment biopsy samples and analyzed with reverse transcriptase-PCR (RT-PCR) assays to determine ERCC1 and RRM1 mRNA expression.
Arm I: Patients receive standard chemotherapy comprising docetaxel IV and carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients are treated according to ERCC1 and RRM1 mRNA expression levels as determined by RT-PCR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients receive standard chemotherapy of docetaxel and carboplatin. |
|
| Arm II, Genotype A1 | Experimental | Patients receive docetaxel and vinorelbine ditartrate. |
|
| Arm II, Genotype A2 | Experimental | Patients receive gemcitabine hydrochloride and vinorelbine ditartrate. |
|
| Arm II, Genotype B1 | Experimental | Patients receive docetaxel and carboplatin. |
|
| Arm II, Genotype B2 | Experimental | Patients receive gemcitabine hydrochloride and carboplatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | Given intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (complete and partial responses) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | ||
| Response duration | ||
| Progression-free survival |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy > 12 weeks
ANC ≥ 1,500/mm³
Hemoglobin > 9.0 g/dL
Platelet count ≥ 100,000/mm³
AST and ALT < 2 times upper limit of normal (ULN)
Bilirubin < 1.5 mg/dL
Creatinine < 1.5 times ULN
Not pregnant or nursing
No serious uncontrolled systemic intercurrent illness, including any of the following:
No other malignancy within the last 5 years, except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Byung Chul Cho | Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cancer Center at Yonsei University Medical Center | Recruiting | Seoul | 120-752 | South Korea |
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| docetaxel | Drug | Given intravenously |
|
| gemcitabine hydrochloride | Drug | Given intravenously |
|
| vinorelbine tartrate | Drug | Given intravenously |
|
| Overall survival |
| Toxicity |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell 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 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
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