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)

NCT ID: NCT00780039

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-01
• Study Completion Date: 2007-09-06

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.

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Caelyx 30 mg/m2 in combination with carboplatin dosed to target AUC of 5 mg/mL.min.

Group Type: EXPERIMENTAL

Pegylated Liposomal Doxorubicin

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

SCH 200746

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Li KJ, Garoff H. Packaging of intron-containing genes into retrovirus vectors by alphavirus vectors. Proc Natl Acad Sci U S A. 1998 Mar 31;95(7):3650-4. doi: 10.1073/pnas.95.7.3650.

Reference Type: RESULT

PMID: 9520420 (View on PubMed)

Power P, Stuart G, Oza A, Provencher D, Bentley JR, Miller WH Jr, Pouliot JF. Efficacy of pegylated liposomal doxorubicin (PLD) plus carboplatin in ovarian cancer patients who recur within six to twelve months: a phase II study. Gynecol Oncol. 2009 Sep;114(3):410-4. doi: 10.1016/j.ygyno.2009.04.037. Epub 2009 Jun 10.

Reference Type: DERIVED

PMID: 19520420 (View on PubMed)

Other Identifiers

P03625

Identifier Type: -

Identifier Source: org_study_id