Expired Study
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New Haven, Connecticut 06520


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00003111


Primary Contact:

Study Chair
John R. Murren, MD
Yale University


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06520
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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