Status:
COMPLETED
Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
Lead Sponsor:
Yonsei University
Conditions:
Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop th...
Detailed Description
OBJECTIVES: Primary * To assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed small cell lung cancer meeting the following criteria:
- Extensive-stage disease
- Previously untreated disease
- At least one measurable disease
- No brain or leptomeningeal metastasis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 mg/dL
- ALT and AST ≤ 2.0 times upper normal limit (ULN) (≤ 5.0 times ULN in the presence of liver metastasis)
- Alkaline phosphatase ≤ 2.0 times ULN
- Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- No active infection requiring intravenous antibiotics
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ cancer
- No other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, interfere with the interpretation of study results, or make the patient ineligible for study entry, in the judgment of the investigator
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No other concurrent chemotherapy, radiotherapy, or immunotherapy
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00754858
Start Date
October 1 2008
End Date
June 1 2012
Last Update
December 2 2014
Active Locations (1)
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1
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, South Korea, 120-752