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A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of 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: NCT01784107
Recruitment Status : Unknown
Verified February 2016 by Eun Kyung Cho, Gachon University Gil Medical Center.
Recruitment status was:  Recruiting
First Posted : February 5, 2013
Last Update Posted : February 10, 2016
Sponsor:
Information provided by (Responsible Party):
Eun Kyung Cho, Gachon University Gil Medical Center

Brief Summary:

Phase 1 : To evaluate MTD(Maximal tolerated dose)and DLT(Dose limiting Toxicity) of Belotecan and Ifosfamide.

Phase 2 : To analyse efficacy and toxicity of Belotecan and Ifosfamide.


Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Belotecan and Ifosfamide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer
Study Start Date : July 2011
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Ifosfamide

Arm Intervention/treatment
Experimental: Belotecan and Ifosfamide Drug: Belotecan and Ifosfamide



Primary Outcome Measures :
  1. MTD (maximal tolerated dose) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. DLT(dose-limiting toxicity) [ Time Frame: one year ]

Other Outcome Measures:
  1. Response rate [ Time Frame: one year ]
  2. PFS(Progression-Free-Survival) [ Time Frame: one year ]
  3. Overall Survival [ Time Frame: one year ]
  4. Number of participants with adverse events [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically confirmed extensive disease of Small cell lung cancer
  • no prior chemotherapy or radiotherapy for lung
  • measurable lesion for RECIST
  • over 18 years
  • ECOG 0~2
  • expected life span more than 3 months

Exclusion Criteria:

  • acute or active infection
  • uncontrolled cerebral nerve symptoms or metastasis
  • significant myocardial infarction or cardiac disease within 12 months

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): NCT01784107


Contacts
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Contact: Hee Kyung Ahn +82-32-460-3229 hkahn@gilhospital.com

Locations
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Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Hee Kyung Ahn    +82-32-460-3229    hkahn@gilhospital.com   
Sponsors and Collaborators
Gachon University Gil Medical Center

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Responsible Party: Eun Kyung Cho, Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01784107    
Other Study ID Numbers: 2011-GIRBA-2550
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Keywords provided by Eun Kyung Cho, Gachon University Gil Medical Center:
SCLC
belotecan
Ifosfamide
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Ifosfamide
Isophosphamide mustard
Belotecan
Camptothecin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic