Clinical trial NCT00065182: Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
Official title: WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer, Non-Small Cell
Non-Small-Cell Lung Cancer
Keywords: HYCAMTIN
TAXOTERE
non-small cell lung cancer
NSCLC
docetaxel
topotecan
Stage IIIB/IV
Advanced
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-07-18
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of a weekly regimen of two FDA approved drugs in combination versus one FDA approved drug in subjects with advanced non-small cell lung cancer who have received one previous chemotherapy excluding TAXOTERE or HYCAMTIN.


Eligibility criteria: Inclusion criteria:

* Written informed consent
* At least 18 years old
* Confirmed advanced non-small cell lung carcinoma (NSCLC)
* Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN. In addition, subjects are allowed to have previously received a non-cytotoxic therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis inhibitor.
* Presence of either measurable or non-measurable disease by radiologic study or physical examination.
* Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy.
* At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
* At least 7 days since prior radiotherapy.
* A probable life expectance of at least 3 months.
* Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.

Exclusion criteria:

* Concomitant malignancies or other malignancies within the last five years.
* Symptoms of brain metastases requiring treatment with steroids.
* Active infection.
* Severe medical problems other than the diagnosis of NSCLC that would limit the ability of the subject to follow study guidelines or expose the subject to extreme risk.
* Ongoing or planned chemotherapy (other than treatment during this study), immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
* Use of investigational drug within 30 days or 5 half-lives prior to the first dose of study medication.
* Women who are pregnant or lactating.
* Subjects of child-bearing potential refusing to practice adequate contraception.
* Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE.
* Subjects who cannot receive steroid premedication.

Primary outcomes:
measure: Median Time of Overall Survival
timeFrame: Up to one year from Day -1 (randomization)
Secondary outcomes:
measure: Number of Participants With One-year Survival
timeFrame: Up to one year from Day -1 (randomization)
measure: Median Time to Progression
timeFrame: Up to one year from Day -1 (randomization)
measure: Response Rate
timeFrame: Up to one year from Day -1 (randomization)
measure: Response Duration
timeFrame: Up to one year from Day -1 (randomization)
measure: Time to Response-assessed Every 8 Weeks
timeFrame: Every 8 Weeks post randomization
measure: Assessment of Quality of Life-assessed Every 4 Weeks
timeFrame: Every 4 Weeks post randomization
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 16 months
measure: Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities
timeFrame: Up to 16 months
measure: Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities
timeFrame: Up to 16 months
measure: Number of Participants With Clinically Significant Abnormal Vital Signs Data
timeFrame: Up to 16 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Poway
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Lakeland
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami Shores
country: United States
facility: GSK Investigational Site
state: Florida
city: Orange Park
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Stuart
country: United States
facility: GSK Investigational Site
state: Florida
city: Columbus
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Illinois
city: Elk Grove Village
country: United States
facility: GSK Investigational Site
state: Illinois
city: Skokie
country: United States
facility: GSK Investigational Site
state: Illinois
city: Urbana
country: United States
facility: GSK Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Bowling Green
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lake Charles
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Frederick
country: United States
facility: GSK Investigational Site
state: Maryland
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Grosse Pointe Woods
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
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: Springfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Reno
country: United States
facility: GSK Investigational Site
state: Nevada
city: Hackensack
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Bronx
country: United States
facility: GSK Investigational Site
state: New York
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
city: East Syracuse
country: United States
facility: GSK Investigational Site
state: New York
city: Manhasset
country: United States
facility: GSK Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: GSK Investigational Site
state: New York
city: Nyack
country: United States
facility: GSK Investigational Site
state: New York
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Dunmore
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Hilton Head Island
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Irving
country: United States
facility: GSK Investigational Site
state: Texas
city: Tyler
country: United States
facility: GSK Investigational Site
state: Texas
city: Abingdon
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Sheboygan
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Casper
country: United States
facility: GSK Investigational Site
state: Wyoming
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Moncton
country: Canada
facility: GSK Investigational Site
state: New Brunswick
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: St. Catharines
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Weston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Levis
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Sainte-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Kielce
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Olsztyn
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Szczecin Zdunowo 20
country: Poland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: