Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC
carboplatin
+ cisplatin
+ irinotecan hydrochloride
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Lung Diseases
Treatment Study
Summary
Study start date: April 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Yale Comprehensive Cancer Center
New Haven, United StatesOpen Yale Comprehensive Cancer Center in Google Maps