Status:
UNKNOWN
First-Line Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
Yonsei University
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination ch...
Detailed Description
OBJECTIVES: * To assess treatment outcomes of adjuvant chemotherapy based on ERCC1 and RRM1 mRNA levels in patients with stage IIIB or IV non-small cell lung cancer. OUTLINE: Patients are randomized...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven or radiologically and clinically suspected stage IIIB (with malignant pleural effusion) or IV non-small cell lung cancer
- Unresectable disease
- At least 1 measurable lesion (\> 10 mm with spiral CT scan or \> 20 mm with conventional CT scan)
- No symptomatic or untreated brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy \> 12 weeks
- ANC ≥ 1,500/mm³
- Hemoglobin \> 9.0 g/dL
- Platelet count ≥ 100,000/mm³
- AST and ALT \< 2 times upper limit of normal (ULN)
- Bilirubin \< 1.5 mg/dL
- Creatinine \< 1.5 times ULN
- Not pregnant or nursing
- No serious uncontrolled systemic intercurrent illness, including any of the following:
- Acute myocardial infarction
- Uncontrolled arrhythmia
- Uncontrolled heart failure
- Sepsis
- Poorly controlled diabetes
- No other malignancy within the last 5 years, except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin
- PRIOR CONCURRENT THERAPY:
- At least 3 weeks since prior radiotherapy, including cranial irradiation
- At least 3 weeks since prior major surgery
- No prior systemic chemotherapy except adjuvant chemotherapy provided it was completed more than 12 months ago
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00736814
Start Date
June 1 2008
Last Update
February 24 2011
Active Locations (1)
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1
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea, 120-752