Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel. Secondary Determine the progression-free and overall survival of patients treated with this regimen. Determine the tolerance profile of this regimen in these patients. Determine the quality of life of patients treated with this regimen. 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.

Official Title
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Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes: Epidermoid carcinoma Large cell carcinoma Adenocarcinoma Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease Inoperable disease Measurable disease At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Platelet count at least 100,000/mm^3 Absolute neutrophil count at least 2,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Bilirubin no greater than normal Transaminases no greater than 1.5 times normal Alkaline phosphatase no greater than 2.5 times normal Renal Creatinine no greater than 2.3 mg/dL Cardiovascular No uncontrolled cardiac insufficiency Other Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study therapy No uncontrolled infection No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No grade 3 or 4 brain disorder No intolerance to polysorbate 80 or cortisones PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy, including taxanes or gemcitabine No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy to more than 20% of the bone marrow No prior radiotherapy for lung cancer At least 4 weeks since other prior radiotherapy and recovered Surgery No prior surgery for lung cancer Other More than 30 days since prior clinical trial participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Tolerability |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, large cell lung cancer, squamous cell lung cancer