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)

NCT00780039 | Completed Phase 2

• 1 other identifier: P03625
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: Pegylated Liposomal Doxorubicin; Drug: Carboplatin

Interventions

Pegylated Liposomal Doxorubicin 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.

Also known as: SCH 200746

Single Arm

Carboplatin 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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Princess Margaret Hospital, Canada: collaborator

Related Publications (2)

• 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.

  PMID: 9520420 RESULT

• 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.

  PMID: 19520420 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

liposomal doxorubicin; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: October 1, 2003
• Primary Completion: September 6, 2007
• Study Completion: September 6, 2007
• Last Updated: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share