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Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00754858
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE September 17, 2008
First Posted Date  ICMJE September 18, 2008
Last Update Posted Date December 2, 2014
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2014)
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2008)
  • Response rate as assessed by RECIST criteria
  • Overall survival
  • Progression-free survival
  • Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
Official Title  ICMJE Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer
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 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.

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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: belotecan hydrochloride
  • Drug: cisplatin
Study Arms  ICMJE Experimental: belotecan and Cisplatin
belotecan 0.5 mg/m2 and Cisplatin 60mg/m2
Interventions:
  • Drug: belotecan hydrochloride
  • Drug: cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2014)
42
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2008)
46
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00754858
Other Study ID Numbers  ICMJE CDR0000614308
YONSEI-4-2008-0127
CKDPC-YONSEI-4-2008-0127
YONSEI-07-YUHS-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joo-Hang Kim, MD Yonsei University
PRS Account Yonsei University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP