Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA 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 combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA non-small cell lung cancer. Investigate the phenotypic changes induced in the tumor by this treatment. OUTLINE: Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 3 courses until disease progression. Once potential candidates for resectability are determined, patients undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of completing the last course of chemotherapy. Following resection, patients responding to chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours. Patients may undergo local irradiation beginning with the second course of carboplatin and paclitaxel. Chemotherapy ceases if disease remains stable after 8 weeks. Patients are followed every 3 months for the first year after treatment, then every 6 months thereafter for survival. PROJECTED ACCRUAL: This study will accrue 20 patients over 18 months.

Official Title
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Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: cisplatin
* Drug: irinotecan hydrochloride
* Drug: paclitaxel
* Procedure: neoadjuvant therapy
* Procedure: surgical procedure
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed, previously untreated stage IIIa (T1-2 N2 M0) non-small cell lung cancer PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Total bilirubin no greater than 1.5 mg/dL Renal: Creatinine clearance at least 55 mL/min Other: Not HIV positive No active infections Not pregnant or lactating Effective contraception required of fertile patients during study participation No coexisting medical condition PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy No concurrent radiation therapy Surgery: Not specified Other: No concurrent use of investigational agents during study participation

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: cisplatin|nan|
|Drug: irinotecan hydrochloride|nan|
|Drug: paclitaxel|nan|
|Procedure: neoadjuvant therapy|nan|
|Procedure: surgical procedure|nan|
|Radiation: radiation therapy|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