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
  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: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 46
Study Start Date: October 2008
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754858

Locations
Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joo-Hang Kim, MD    82-2-2228-8131    kjhang@yuhs.ac   
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Joo-Hang Kim, MD Yonsei University
  More Information

Additional Information:
No publications provided

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
Study First Received: September 17, 2008
Last Updated: March 12, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Belotecan
Cisplatin
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014