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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)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00780039
First received: October 23, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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 Lyposomal 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 Intervention Phase
Ovarian Neoplasms
 Drug: Pegylated Lyposomal Doxorubicin
Drug: Carboplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: October 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Caelyx 30 mg/m2 in combination with carboplatin dosed to target AUC of 5 mg/mL.min.
 Drug: Pegylated Lyposomal 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00780039     History of Changes
Other Study ID Numbers: P03625
Study First Received: October 23, 2008
Last Updated: October 23, 2008
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Neoplasms
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
Doxorubicin
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013