Ovarian Neoplasms
Conditions
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 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.
Interventions
DRUGPegylated 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.
DRUGCarboplatin
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.
Sponsors
Princess Margaret Hospital, Canada
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>=18 years old * Subject must have histological diagnosis of epithelial ovarian cancer * Subject must have received a taxane and platinum regimen and have maintained a treatment-free status for at least six months and not more than twelve months following completion of first line therapy. * Subject must have measurable ovarian cancer by appropriate radiological imaging. * ECOG performance Score of 0 or 1. * Subject's life expectancy must be \> 6 months. * Subject must have normal organ function, except if abnormal due to tumor involvement: * Adequate bone marrow function (platelets \>=100 X 10\^9/L, hemoglobin \>=100 g/L, neutrophils \>=1.5 X 10\^9/L) * Adequate renal function (serum creatinine\<=1.5 X the upper limit of normal (ULN) * Adequate liver function (bilirubin and AST or ALT\<=2 times ULN, unless related to primary disease. * MUGA scan must indicate left ventricular ejection fraction above 90%. * Women of childbearing potential must be using adequate contraception (prescribed under medical supervision) and have a negative pregnancy test at the time of enrollment. * Subject must be able to sign written informed consent.
Exclusion criteria
* Subject who is pregnant or is breast feeding. * Subject who has history of cardiac disease, with New York Heart Association Class II or greater. * Subject with a history of severe hypersensitivity reactions to products containing Cremophor® EL. * Subject with clinically significant hepatic disease. * Subject who has uncontrolled bacterial, viral, or fungal infection. * Subject who exhibits confusion or disorientation. * Subject with any condition that would prevent adequate follow-up. * Subject with a history of prior malignancy treated with systemic chemotherapy or radiotherapy. * Subject who has received two or more prior chemotherapy regimens for ovarian cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate, according to RECIST criteria; Partial response rate, according to RECIST criteria | 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
| Measure | Time frame |
|---|---|
| Safety and tolerability; Duration of response; CA-125 response; Time to progression; Overall survival | All patients will be followed for a minimum of one year for survival |
Outcome results
None listed