The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer Clinical Trial

— (SCLC)  

Official title:

A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043862
• Other study ID #: 104864/535
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2002
• Last updated: May 30, 2017
• Start date: August 2002

Study information

• Verified date: March 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.

• Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.

• Patients must give written informed consent to participate in the study.

• Patients must be able to take oral medication.

• Patients should be completely recovered from recent surgery.

• Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

• Patients must be evaluated by the radiation oncologist prior to study entry.

Exclusion Criteria:

• Extensive Stage SCLC.

• Women who are pregnant or lactating.

• Use of an investigational drug within 30 days prior to the first dose of study medication.

• Any medically/clinically significant active infection.

• Symptoms of the SCLC spreading to the brain.

• Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy.

• Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk.

• Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.

Related Conditions & MeSH terms

• Lung Cancer, Small Cell
• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• topotecan

Locations

Country	Name	City	State
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Bakersfield	California
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Duluth	Minnesota
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Green Bay	Wisconsin
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	La Crosse	Wisconsin
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Robbinsdale	Minnesota
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Scarborough	Maine
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	St. Louis	Montana
United States	GSK Investigational Site	Toledo	Ohio
United States	GSK Investigational Site	Wausau	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate
Secondary	Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability