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)

PHASE2CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

October 1, 2003

Primary Completion Date

September 6, 2007

Study Completion Date

September 6, 2007

Conditions
Ovarian Neoplasms
Interventions
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.

DRUG

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.

All Listed Sponsors
collaborator

Princess Margaret Hospital, Canada

OTHER

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00780039 - 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) | Biotech Hunter | Biotech Hunter