Paclitaxel in Treating Patients With Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.

Detailed Description
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OBJECTIVES: Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC). Assess the duration of response in patients presenting with an objective response. Characterize the acute side effects of paclitaxel in patients with BAC. Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation. OUTLINE: This is an open label, nonrandomized, multicenter study. Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur. Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs. PROJECTED ACCRUAL: 16 or 25 patients will be accrued.

Official Title
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Phase II Study on TAXOL in Bronchioalveolar Carcinoma

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven bronchoalveolar carcinoma (BAC) based on these criteria: Absence of primary adenocarcinoma elsewhere Absence of a demonstrable central bronchogenic origin A peripheral location in the lung parenchyma Intact interstitial framework of the lung A histological appearance setting it apart from other tumors, with a characteristic pattern of growth: cuboidal or cylindrical cells lining up the alveolar septa with preservation of basic pulmonary architecture Must be unresectable Stage IIIB, IV, or recurrent BAC Evidence of multinodular lesions involving the lungs bilaterally or unilaterally (in the latter the lesions must involve more than one lobe) At least one target lesion bidimensionally measurable that has not undergone prior irradiation No CNS disease PATIENT CHARACTERISTICS: Age: 18 to 75 (inclusive) Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: ANC at least 1,500/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal SGOT, SGPT, and alkaline phosphatase less than 2 times upper limit of normal Renal: Creatinine less than 1.5 times upper limit of normal Cardiovascular: No history of ischemic or congestive heart disease No arrhythmia requiring chronic cardiopulmonary medications No history of clinically or electrographically documented myocardial infarction Other: No preexisting motor or other serious sensory neurotoxicity No active or prior second primary cancer except basal cell carcinoma of the skin or carcinoma in situ of the cervix No clinical evidence of uncontrolled infection Not pregnant or nursing Negative pregnancy test 72 hours prior to start of study medication Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy Must have at least one bidimensional lesion outside the irradiated fields Surgery: Fully recovered from any prior major surgery

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
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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