Clinical trial NCT00043862: The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer, Small Cell
Small Cell Lung Cancer
Keywords: Hycamtin
oral
Radiation Sensitization
Small Cell Lung Cancer
newly diagnosed
limited stage
topotecan
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2002-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Bakersfield
country: United States
facility: GSK Investigational Site
state: California
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Scarborough
country: United States
facility: GSK Investigational Site
state: Maine
city: Springfield
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Duluth
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Robbinsdale
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Montana
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Akron
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: GSK Investigational Site
state: Ohio
city: Toledo
country: United States
facility: GSK Investigational Site
state: Ohio
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Green Bay
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: La Crosse
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Wausau
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: