Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Sarah Cannon Research Institute

ClinicalTrials.gov Identifier:

NCT00294190

First received: February 16, 2006

Last updated: December 6, 2012

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 16, 2006

Last Updated Date

December 6, 2012

Start Date ^ICMJE

February 2006

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Overall response rate

Change History

Complete list of historical versions of study NCT00294190 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

overall toxicity [ Time Frame: 18 months ] [ Designated as safety issue: No ]
time to progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
duration of response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

overall toxicity
time to progression
duration of response
overall survival

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Official Title ^ICMJE

A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Brief Summary

This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.

Detailed Description

All patients will receive weekly topotecan.

Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)

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

Small Cell Lung Cancer
Carcinoma, Small Cell

Intervention ^ICMJE

Drug: Topotecan

Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.

Other Name: Hycamtin

Study Arm (s)

Experimental: Topotecan

Intervention: Drug: Topotecan

Publications *

Spigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. Epub 2011 Apr 28.

* 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

Completed

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

September 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
Measurable or evaluable disease
Able to perform activities of daily living with minimal assistance
Adequate bone marrow, liver and kidney function
May have received no more than 3 previous courses of radiation therapy
Give written informed consent prior to study entry

Exclusion Criteria:

Patients with limited stage disease
History of a prior malignancy within three years
Female patients who are pregnant or are breast feeding
Significant history of uncontrolled cardiac disease
Myocardial infarction or stroke within six months
Symptomatic peripheral vascular disease
CNS involvement
Serious active infection or underlying medical condition

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00294190

Other Study ID Numbers ^ICMJE

SCRI LUN 120, 105642

Has Data Monitoring Committee

Responsible Party

Sarah Cannon Research Institute

Study Sponsor ^ICMJE

Sarah Cannon Research Institute

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

David R. Spigel, MD

Sarah Cannon Research Institute

Information Provided By

Sarah Cannon Research Institute

Verification Date

May 2011

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

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