At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 77 enrolled
Drug / intervention
topotecan +1 moredrug
Likely dose
topotecan 2.0 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating topotecan and CARBOPLATIN for Ovarian Cancer and Neoplasms, Ovarian. Completed, enrolled 77 participants across 22 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Neoplasms, Ovarian
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
First PostedApr 2006
Primary CompletionJan 2009
Study CompletionMar 2009
TodayJul 2026
First PostedApr 20, 2006
Enrollment StartMar 1, 2005
Primary CompletionJan 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.2 years ago
Interventions
topotecandrug
HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1
CARBOPLATINdrug
HYCAMTIN at a dose of 2.0 mg/m2 on Days 1 and 8 every 21 days followed by carboplatin at AUC 5 on Day 1