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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-62199 | |||
| AVENTIS-CCCWFU-62199 | |||
| AG-CCCWFU-62199 | |||
| CCCWFU-BG99-322 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with recurrent stage III or stage IV non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | 40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days | ||
| gemcitabine hydrochloride | Drug | 800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated. |
| Measure | Description | Time Frame |
|---|---|---|
| patient response rate to weekly taxotere and gemcitabine | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate toxicity of weekly Taxotere and Gemcitabine | 6 weeks |
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DISEASE CHARACTERISTICS:
Histologically confirmed stage IIIB or IV non-small cell lung cancer, including any of the following types:
Histologic or cytologic documentation of recurrence is required
Measurable or evaluable disease, defined as any mass reproducibly measurable in 2 perpendicular diameters by physical examination or imaging
The following lesions are not considered measurable or evaluable:
CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 2 weeks since prior major surgery and recovered from acute effects
At least 2 weeks since prior palliative radiotherapy and recovered from acute toxic effects
No prior chemotherapy
No concurrent cranial or thoracic radiation therapy
No concurrent cytotoxic or hormonal therapy
Concurrent palliative radiotherapy allowed for relief of localized pain and obstruction
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| Name | Affiliation | Role |
|---|---|---|
| Antonius A. Miller, MD | Wake Forest University Health Sciences | Study Chair |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| 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 |
| 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 |