Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery

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. It is not yet known whether paclitaxel and carboplatin is more effective than standard chemotherapy for advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV non-small cell lung cancer that cannot be removed during surgery.

Detailed Description
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OBJECTIVES: Compare the one and two year survival of patients with inoperable advanced non-small cell lung cancer treated with paclitaxel and cisplatin versus standard platinum therapy. Compare the toxic effects of these two regimens in this patient population. Compare the performance status, tumor response, and quality of life in these patients after these treatment regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, stage of disease (IIIA vs IIIB vs IV), or performance status (ECOG O vs 1 vs 2 vs 3). Patients are randomized to one of two treatment arms: Arm I: Patients receive paclitaxel IV over 3 hours, followed by carboplatin IV over 30 minutes on day 1. Arm II: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1 OR mitomycin IV, vinblastine IV, and cisplatin IV over 4 hours on day 1. Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each treatment course. Patients are followed for survival. PROJECTED ACCRUAL: Approximately 300 patients (150 per treatment arm) will be accrued for this study.

Official Title
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A Randomized Phase III Comparative Study of Paclitaxel With Carboplatin Versus Mitomycin, Ifosfamide, Cisplatin (MIC) Chemotherapy in Inoperable Advanced Stage Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: cisplatin
* Drug: ifosfamide
* Drug: mitomycin C
* Drug: paclitaxel
* Drug: vinblastine sulfate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed inoperable advanced non-small cell lung cancer Stage IIIA, IIIB, or IV Not eligible for curative radiotherapy or surgery Measurable or evaluable disease No bony lesions as only site of measurable disease No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 (ECOG 3 allowed in some cases) Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases) Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Other: Not pregnant Fertile patients must use effective contraception during and for 3 months after study No active infection No other serious systemic disorder that would preclude compliance No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed if measurable disease outside of irradiated field Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 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: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|
|Drug: ifosfamide|nan|
|Drug: mitomycin C|nan|
|Drug: paclitaxel|nan|
|Drug: vinblastine sulfate|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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stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer