Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00754858|
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : December 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: belotecan hydrochloride Drug: cisplatin||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer|
|Study Start Date :||October 2008|
|Primary Completion Date :||May 2010|
|Study Completion Date :||June 2012|
Experimental: belotecan and Cisplatin
belotecan 0.5 mg/m2 and Cisplatin 60mg/m2
|Drug: belotecan hydrochloride Drug: cisplatin|
- Response rate as assessed by RECIST criteria [ Time Frame: 21days(1cycle) ]
- Overall survival [ Time Frame: 21days(1cycle) ]
- Progression-free survival [ Time Frame: 21days(1cycle) ]
- Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: 21days(1cycle) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|