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)
|ClinicalTrials.gov Identifier: NCT00780039|
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : May 15, 2017
Merck Sharp & Dohme Corp.
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 Liposomal 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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms||Drug: Pegylated Liposomal Doxorubicin Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-free Interval) Relapsed Epithelial Ovarian Cancer.|
|Actual Study Start Date :||October 1, 2003|
|Primary Completion Date :||September 6, 2007|
|Study Completion Date :||September 6, 2007|
Resource links provided by the National Library of Medicine
U.S. FDA Resources
Experimental: Single Arm
Caelyx 30 mg/m2 in combination with carboplatin dosed to target AUC of 5 mg/mL.min.
Drug: Pegylated Liposomal Doxorubicin
Subjects will receive Caleyx 30 mg/m2 intravenously on Day 1 of each 4-week cycle, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
Other Name: SCH 200746Drug: Carboplatin
Subjects will receive carboplatin dosed to target AUC of 5 mg/mL.min, intravenously, on Day 1 of each 4-week cycle, after the Caelyx infusion, during 6 cycles. Patients still achieving clinical benefit after a total of 6 cycles may continue therapy.
Primary Outcome Measures :
- 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 ]
Secondary Outcome Measures :
- 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 ]
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