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Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.

NCT00319969 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2009-09-30

No results posted yet for this study

Summary

The purpose of the study is to evaluate the objective tumor response rate of amrubicin or standard topotecan therapy when administered as second-line therapy to ED-SCLC patients who have chemotherapy sensitive recurrent or progressive.

Conditions

Interventions

DRUG

Amrubicin

Amrubicin 40mg/m\<2\> IV days 1, 2, 3 of each 21-day cycle until disease progression.

DRUG

Topotecan

Topotecan 1.5mg/m\<2\> IV days 1, 2, 3, 4, 5 of each 21-day cycle until disease progression.

Sponsors & Collaborators

  • Celgene Corporation

    lead INDUSTRY

Principal Investigators

  • Richard S Ungerleider, MD · Theradex

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-07-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319969 on ClinicalTrials.gov