Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

This study has been terminated.

(Slow Accrual)

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

Aultman Hospital

ClinicalTrials.gov Identifier:

NCT00315211

First received: April 17, 2006

Last updated: October 31, 2007

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

April 17, 2006

Last Updated Date

October 31, 2007

Start Date ^ICMJE

November 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To determine the overall response rate of patients treated with at least two cycles of this regimen [ Time Frame: 3 years ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00315211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Official Title ^ICMJE

Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer

Brief Summary

The purposes of this study are:

To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Mediastinal Neoplasms

Intervention ^ICMJE

Drug: Intravenous Topotecan
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
Drug: Intravenous Docetaxel
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 & 8 of a 21 day cycle

Study Arm (s)

Arm A

Interventions:

Drug: Intravenous Topotecan
Drug: Intravenous Docetaxel

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Recurred greater than 90 days after initial treatment
At least 1 measurable lesion
Only 1 prior chemotherapy
Must be over 18 years of age
ECOG performance status of 0 - 2
Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

No prior use of topotecan, docetaxel, or irinotecan
No symptomatic brain metastases
History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
No prior investigational agents within 1 month prior
Lung cancer of mixed histology
Known uncontrolled seizure disorders

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00315211

Other Study ID Numbers ^ICMJE

Hycamtin study #102143, Aultman Lung 01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Aultman Hospital

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Raza Khan, MD

Aultman Hospital

Information Provided By

Aultman Hospital

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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