Gemcitabine and Docetaxel in Treating Patients With Recurrent Stage III 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, 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.

Detailed Description
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OBJECTIVES: Primary Determine the response rate of patients with recurrent stage IIIB and IV non-small cell lung cancer treated with gemcitabine hydrochloride and docetaxel. Determine the overall and progression-free survival of patients treated with this regimen. Determine the toxic effects of this regimen in these patients. Secondary Determine the duration of response in patients treated with this regimen. 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.

Official Title
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A Phase II Study of Taxotere and Gemcitabine for Stages III-B and 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 confirmed stage IIIB or IV non-small cell lung cancer, including any of the following types: Squamous cell carcinoma Adenocarcinoma, including bronchoalveolar cell adenocarcinoma Large cell anaplastic carcinoma, including giant and clear cell carcinomas 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: Bone disease only Pleural or pericardial effusions Previously irradiated lesions, unless subsequent progression is documented CNS metastases allowed provided the patient undergoes at least 2 weeks of radiotherapy prior to study entry PATIENT CHARACTERISTICS: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test CALGB performance status ≤ 1 Life expectancy ≥ 3 months Granulocyte count > 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Creatinine ≤ 2 times normal Bilirubin normal SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase ≤ 1.5 times ULN OR Alkaline phosphatase 4 times ULN and SGOT and/or SGPT normal Ejection fraction normal by ECHO or MUGA No history of congestive heart failure No psychiatric illness that would preclude study compliance No serious medical or psychiatric illness that would preclude giving informed consent or limit survival to < 3 months No active uncontrolled bacterial, fungal, or viral infection No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or breast, basal cell or squamous carcinoma of the skin, or other surgically resected non-recurrent primary tumor not treated with adjuvant radiotherapy or chemotherapy No pre-existing peripheral neuropathy ≥ grade 2 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 Any persistent toxicity (e.g., alopecia or hyperpigmentation) not associated with clinical morbidity allowed 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|40 milligrams per meter squared infused over 30 minutes on day 1 and 8, repeated every 21 days|
|Drug: gemcitabine hydrochloride|800 milligrams per meter squared intraveneously for two consecutive weeks followe by one week of no treatment then repeated.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient response rate to weekly taxotere and gemcitabine |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate toxicity of weekly Taxotere and Gemcitabine |  | 6 weeks | 

 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, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer