Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

Non-Small-Cell Lung Cancer Clinical Trial

Official title:

WEEKLY IV TOPOTECAN/DOCETAXEL COMBINATION COMPARED TO DOCETAXEL IN PATIENTS WITH PRETREATED ADVANCED NSCLC: AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE III TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065182
• Other study ID #: 104864/615
• Secondary ID: 2004-002892-17
• Status: Completed
• Phase: Phase 2
• Start date: August 14, 2003
• Est. completion date: August 30, 2007

Study information

• Verified date: March 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 399
• Est. completion date: August 30, 2007
• Est. primary completion date: August 30, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Topotecan/Docetaxel combination

• Docetaxel

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	Kitchener	Ontario
Canada	GSK Investigational Site	Levis	Quebec
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Moncton	New Brunswick
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	St. Catharines	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Weston	Ontario
Poland	GSK Investigational Site	Kielce
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Szczecin Zdunowo 20
United States	GSK Investigational Site	Abingdon	Virginia
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Bowling Green	Kentucky
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Casper	Wyoming
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Decatur	Illinois
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Dunmore	Pennsylvania
United States	GSK Investigational Site	East Syracuse	New York
United States	GSK Investigational Site	Elk Grove Village	Illinois
United States	GSK Investigational Site	Fayetteville	North Carolina
United States	GSK Investigational Site	Frederick	Maryland
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Grosse Pointe Woods	Michigan
United States	GSK Investigational Site	Hackensack	New Jersey
United States	GSK Investigational Site	Hilton Head Island	South Carolina
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Irving	Texas
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Lafayette	Louisiana
United States	GSK Investigational Site	Lake Charles	Louisiana
United States	GSK Investigational Site	Lakeland	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Manhasset	New York
United States	GSK Investigational Site	Miami Shores	Florida
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Hyde Park	New York
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Nyack	New York
United States	GSK Investigational Site	Orange Park	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Poway	California
United States	GSK Investigational Site	Reno	Nevada
United States	GSK Investigational Site	Robbinsdale	Minnesota
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Sheboygan	Wisconsin
United States	GSK Investigational Site	Skokie	Illinois
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Stuart	Florida
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tyler	Texas
United States	GSK Investigational Site	Urbana	Illinois
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Time of Overall Survival	Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment.	Up to one year from Day -1 (randomization)
Secondary	Number of Participants With One-year Survival	Number of participants with one-year survival were planned to be reported.	Up to one year from Day -1 (randomization)
Secondary	Median Time to Progression	Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression.	Up to one year from Day -1 (randomization)
Secondary	Response Rate	Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response.	Up to one year from Day -1 (randomization)
Secondary	Response Duration	Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression.	Up to one year from Day -1 (randomization)
Secondary	Time to Response-assessed Every 8 Weeks	Time to response is defined as the time between randomization and the first radiologically documented complete or partial response.	Every 8 Weeks post randomization
Secondary	Assessment of Quality of Life-assessed Every 4 Weeks	The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be).	Every 4 Weeks post randomization
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant.	Up to 16 months
Secondary	Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities	Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented.	Up to 16 months
Secondary	Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities	Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented.	Up to 16 months
Secondary	Number of Participants With Clinically Significant Abnormal Vital Signs Data	Vital sign parameters included (blood pressure, and pulse rate after five minutes sitting, body temperature). Blood pressure and pulse rate was measured after sitting for 5 minutes. Only participants with clinically significant abnormal Vital sign data was reported.	Up to 16 months