Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind. Determine the feasibility and toxicity of this regimen in these patients. Determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs. Patients are followed every 3 months for 2 years and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.

Official Title
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A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: exisulind
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined modality therapy OR Stage IV Prior brain metastases are allowed provided the following are true: Patient completed radiotherapy and/or surgery at least 3 weeks prior to study Objective evidence of resolution or significant improvement of brain lesions exists on follow-up CT scan or MRI Patient is neurologically improved or stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 WBC at least 3,000/mm^3 Hemoglobin at least 9 g/L Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 mg/dL SGOT no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No prior uncontrolled cardiovascular disease No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective nonhormonal contraception No serious active infection No dementia or active psychoses No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer curatively treated with surgery or small-field radiotherapy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 1 month since prior investigational agents More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors, or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen) No concurrent sulindac or COX-2 inhibitors

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: exisulind|nan|
|Drug: gemcitabine hydrochloride|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