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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)

Primary Purpose

Ovarian Neoplasms

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Pegylated Liposomal Doxorubicin

Carboplatin

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Complete response rate, according to RECIST criteria; Partial response rate, according to RECIST criteria

Secondary Outcome Measures

Safety and tolerability; Duration of response; CA-125 response; Time to progression; Overall survival

Full Information

NCT ID

NCT00780039

First Posted

October 23, 2008

Last Updated

May 12, 2017

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Princess Margaret Hospital, Canada

1. Study Identification

Unique Protocol Identification Number

NCT00780039

Brief Title

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)

Official Title

Phase II, Open-Label, Study of CAELYX and Carboplatin Intermediate Platinum-Sensitive (6-12 Months Treatment-free Interval) Relapsed Epithelial Ovarian Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

October 1, 2003 (Actual)

Primary Completion Date

September 6, 2007 (Actual)

Study Completion Date

September 6, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

Collaborators

Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pegylated Liposomal Doxorubicin

Other Intervention Name(s)

SCH 200746

Intervention Description

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

Intervention Name(s)

Carboplatin

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

9520420

Citation

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.

Results Reference

result

PubMed Identifier

19520420

Citation

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.

Results Reference

derived

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