A Phase Ib/II Trial of Belotecan and Ifosfamide in Patients With Extensive Disease of Small Cell Lung Cancer

February 9, 2016 updated by: Eun Kyung Cho, Gachon University Gil Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Belotecan and Ifosfamide
Drug: Belotecan and Ifosfamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MTD (maximal tolerated dose)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
DLT(dose-limiting toxicity)
Time Frame: one year
one year

Other Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: one year
one year
Overall Survival
Time Frame: one year
one year
PFS(Progression-Free-Survival)
Time Frame: one year
one year
Number of participants with adverse events
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

January 30, 2013

First Submitted That Met QC Criteria

February 3, 2013

First Posted (ESTIMATE)

February 5, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-GIRBA-2550

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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