Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-Stage Small-Cell Lung Cancer
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 lung cancer.
Secondary
- To assess additional evidence of antitumor activity as measured by overall and
progression-free survival of these patients.
- To determine the safety and tolerability of this drug combination in these patients.
OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days
2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate as assessed by RECIST criteria
No
Joo-Hang Kim, MD
Principal Investigator
Yonsei University
Unspecified
CDR0000614308
NCT00754858
October 2008
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