Status:
COMPLETED
Carboplatin, Irinotecan, and Radiation Therapy Followed By Docetaxel in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
University of Miami
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from di...
Detailed Description
OBJECTIVES: Primary * Determine the objective response rate in patients with newly diagnosed stage IIIA or IIIB non-small cell lung cancer treated with concurrent carboplatin, irinotecan hydrochlori...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIA or IIIB disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan
- No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB wet disease)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL
- Bilirubin normal
- Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:
- AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
- AP ≤ 5 times ULN AND AST or ALT normal
- Creatinine \< 2.0 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No New York Heart Association class III-IV heart disease
- No history of serious cardiac disease not adequately controlled
- No documented myocardial infarction within the past 6 months
- No congestive heart failure
- No unstable angina
- No clinically significant arrhythmia
- No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- No peripheral neuropathy \> grade 1
- No other malignancy within the past 5 years other than skin cancer
- PRIOR CONCURRENT THERAPY:
- More than 3 weeks since prior major surgery
- No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for NSCLC
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00449020
Start Date
January 1 2004
End Date
January 1 2008
Last Update
December 15 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136