Clinical trial NCT01004380: Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer
Official title: A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epithelial Ovarian Cancer
Keywords: Epithelial Ovarian Cancer
Ovarian Cancer
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2009-10-29
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.

Detailed description: Farletuzumab (MORAb-003) is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) in combination with other drugs. Farletuzumab works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if the combination therapy of farletuzumab, carboplatin, and PLD

1. is safe, or
2. to assess the potential drug-drug interaction, and
3. to prolong response to chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of epithelial ovarian cancer
* Must have measurable disease by CT or MRI scan
* Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy
* Must have been treated with surgery and be a candidate for repeat carboplatin therapy
* Must have a normal cardiac ejection fraction at baseline

Exclusion Criteria:

* Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs \<6 months from the last platinum therapy
* Subjects who have received other therapy to treat their ovarian cancer since last relapse
* Known central nervous system tumor involvement
* Evidence of other active invasive malignancy
* Clinically significant heart disease
* Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
* Previous treatment with MORAb 003 (farletuzumab)
* Previous treatment with anthracyclines
* Clinical contraindications to use PLD

Primary outcomes:
measure: To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.
timeFrame: At all study visits.
Secondary outcomes:
measure: To assess the effect of farletuzumab in combination with carboplatin and PLD on best objective response rate, time to response, and duration of response by RECIST criteria.
timeFrame: Every 2 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Medical Center
state: Alabama
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Brightwaters
country: United States
facility: Schwartz Gynecologic Oncology
state: New York
city: Chattanooga
country: United States
facility: Chattanooga GYN Oncology
state: Tennessee
city: Harlingen
country: United States
facility: International Beneficence Clinical Research, LLC
state: Texas
Study officials:
affiliation: Morphotek
name: Susan Weil, MD
role: STUDY_DIRECTOR
References: