Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer
- Conditions
- Ovarian CancerNeoplasms, Ovarian
- Interventions
- Registration Number
- NCT00316173
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study was designed to find the most effective and safest doses of both HYCAMTIN and CARBOPLATIN that can be given for the treatment of ovarian cancer. This study may allow researchers to determine the effectiveness of combining HYCAMTIN and CARBOPLATIN.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 77
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single-arm topotecan HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days Single-arm CARBOPLATIN HYCAMTIN at a dose of 2.0 - 2.5mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1, every 21 days
- Primary Outcome Measures
Name Time Method Number of Participants With the Indicated Response From start of treatment to evidence of CR or PR (up to 39.3 weeks). 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).
- Secondary Outcome Measures
Name Time Method Time to Response From start of treatment to evidence of PR or CR (up to 39.3 weeks) Time to response was calculated as the time from start of treatment until first evidence of partial response (PR; \>50% decrease in the measurements of the largest lesions with no appearance of new lesions) or complete response (CR; complete disappearance of all lesions).
Duration of Response From time of PR or CR to disease progression/death (up to 56.0 weeks) Duration of response was calculated as the time from first documented PR or CR until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was "censored".
Progression-free Survival From start of treatment to disease progression/death (up to 67.7 weeks) Progression-free survival (PFS) was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was "censored". Although "Time to Disease Progression" was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of "PFS". As such, "PFS" was measured, not "Time to Disease Progression".
Number of Participants Who Died From the Start of Treatment to Follow-up From start of treatment to death (up to 110.4 weeks). The number of participants who died from the start of treatment to follow-up was calculated. For participants who did not die, the date of last contact was used. The word used for such participants was "censored".
The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125) Baseline to end of study (up to 54.7 weeks). CA-125 is a "tumor marker", found in greater concentration in tumor cells than other cells of the body. Participants were classed as responders if their CA-125 level at the end of study was 50% or less of baseline. In addition, a confirmatory sample (taken at least 28 days after the first sample) must have also been 50% or less of baseline.
Time to Disease Progression From start of treatment to disease progression/death Although "Time to Disease Progression" was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of "Progression-free Survival". As such, "Progression-free Survival" was measured, not "Time to Disease Progression". See the outcome measure entitled "Progression-free Survival" for data pertaining to time to disease progression.
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇦Quebec, Canada