An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With the Indicated Response
Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization [WHO] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: >50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: >25% increase in measurements of lesions or appearance of new lesions).
From start of treatment to evidence of CR or PR (up to 39.3 weeks).
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
Canada: Canadian Institutes of Health Research
104864/902
NCT00316173
March 2005
March 2009
Name | Location |
---|---|
GSK Investigational Site | Bakersfield, California 93309 |
GSK Investigational Site | Indianapolis, Indiana 46260 |
GSK Investigational Site | Raleigh, North Carolina 27609 |
GSK Investigational Site | Akron, Ohio 44304 |
GSK Investigational Site | Green Bay, Wisconsin 54301 |
GSK Investigational Site | Savannah, Georgia 31405 |
GSK Investigational Site | Columbia, South Carolina 29210 |
GSK Investigational Site | New York, New York 10021 |
GSK Investigational Site | Hartford, Connecticut 06106 |
GSK Investigational Site | Henderson, Nevada 89014 |
GSK Investigational Site | Salt Lake City, Utah 84107 |
GSK Investigational Site | Seattle, Washington 98133 |