Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
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 the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer|
- Response rate as assessed by RECIST criteria [ Time Frame: 21days(1cycle) ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 21days(1cycle) ] [ Designated as safety issue: Yes ]
- Progression-free survival [ Time Frame: 21days(1cycle) ] [ Designated as safety issue: Yes ]
- Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: 21days(1cycle) ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: belotecan and Cisplatin
belotecan 0.5 mg/m2 and Cisplatin 60mg/m2
|Drug: belotecan hydrochloride Drug: cisplatin|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754858
|Korea, Republic of|
|Yonsei Cancer Center at Yonsei University Medical Center|
|Seoul, Korea, Republic of, 120-752|
|Principal Investigator:||Joo-Hang Kim, MD||Yonsei University|