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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780039
Recruitment Status : Completed
First Posted : October 24, 2008
Last Update Posted : May 15, 2017
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

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)
Primary Purpose: Treatment
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
Actual Primary Completion Date : September 6, 2007
Actual Study Completion Date : September 6, 2007

Arm Intervention/treatment
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 200746
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.

Primary Outcome Measures :
  1. 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 :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00780039     History of Changes
Other Study ID Numbers: P03625
First Posted: October 24, 2008    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Liposomal doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action