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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00754858
First Posted: September 18, 2008
Last Update Posted: December 2, 2014
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.
Information provided by (Responsible Party):
Yonsei University
  Purpose

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 Intervention Phase
Lung Cancer Drug: belotecan hydrochloride Drug: cisplatin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 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) ]

Enrollment: 42
Study Start Date: October 2008
Study Completion Date: June 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: belotecan and Cisplatin
belotecan 0.5 mg/m2 and Cisplatin 60mg/m2
Drug: belotecan hydrochloride Drug: cisplatin

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754858


Locations
Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Joo-Hang Kim, MD Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT00754858     History of Changes
Other Study ID Numbers: CDR0000614308
YONSEI-4-2008-0127
CKDPC-YONSEI-4-2008-0127
YONSEI-07-YUHS-02
First Submitted: September 17, 2008
First Posted: September 18, 2008
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Yonsei University:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Belotecan
Cisplatin
Camptothecin
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic