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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00754858
First received: September 17, 2008
Last updated: March 12, 2009
Last verified: December 2008

September 17, 2008
March 12, 2009
October 2008
May 2010   (final data collection date for primary outcome measure)
  • Response rate as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00754858 on ClinicalTrials.gov Archive Site
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Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer
Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in 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.

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
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: belotecan hydrochloride
  • Drug: cisplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
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May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
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Korea, Republic of
 
NCT00754858
CDR0000614308, YONSEI-4-2008-0127, CKDPC-YONSEI-4-2008-0127, YONSEI-07-YUHS-02
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Yonsei University
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Principal Investigator: Joo-Hang Kim, MD Yonsei University
National Cancer Institute (NCI)
December 2008

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