A Study to Evaluate the Safety and Efficacy of Caelyx in Combination With Carboplatin in Patients With Ovarian Cancer Recurrent Within Six to Twelve Months After Initial Carboplatin and Paclitaxel Chemotherapy (P03625)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00780039
First received: October 23, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
Tracking Information | |
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First Received Date ICMJE | October 23, 2008 |
Last Updated Date | October 23, 2008 |
Start Date ICMJE | October 2003 |
Primary Completion Date | September 2007 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Complete response rate, according to RECIST criteria; Partial response rate, according to RECIST criteria [ Time Frame: Complete or partial response: re-evaluation 4 weeks later to confirm response; Upon completion of chemotherapy: follow-up every 2 months until documentation of progressive disease; All patients will be followed for a minimum of one year for survival ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE |
Safety and tolerability; Duration of response; CA-125 response; Time to progression; Overall survival [ Time Frame: All patients will be followed for a minimum of one year for survival ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | A Study to Evaluate the Safety and Efficacy of Caelyx in Combination With Carboplatin in Patients With Ovarian Cancer Recurrent Within Six to Twelve Months After Initial Carboplatin and Paclitaxel Chemotherapy (P03625)(COMPLETED) |
Official Title ICMJE | Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-Free Interval) Relapsed Epithelial Ovarian Cancer. |
Brief Summary | Doxorubicin has been used to treat ovarian cancer as part of different combination therapies, but high cumulative doses should be avoided because of the risk of cardiotoxicity. Pegylated Lyposomal Doxorubicin (Caelyx) has been developed to reduce the risk of cardiotoxicity. The purpose of this study is to evaluate the safety and efficacy of Caelyx in combination with carboplatin in women with recurrent ovarian cancer. |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE | Ovarian Neoplasms |
Intervention ICMJE |
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Study Arm (s) | Experimental: Single Arm
Caelyx 30 mg/m2 in combination with carboplatin dosed to target AUC of 5 mg/mL.min.
Interventions:
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 58 |
Completion Date | September 2007 |
Primary Completion Date | September 2007 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00780039 |
Other Study ID Numbers ICMJE | P03625 |
Has Data Monitoring Committee | No |
Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
Study Sponsor ICMJE | Schering-Plough |
Collaborators ICMJE | Princess Margaret Hospital, Canada |
Investigators ICMJE | |
Information Provided By | Schering-Plough |
Verification Date | October 2008 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |