The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.
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) either alone or in combination with other drugs. MORAb-003 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 MORAb-003 can work either as a single agent 1. to treat a CA125-only relapse, or 2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic relapse, and 3. to prolong a second response to chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Weekly Farletuzumab infusions Dose dependent on dosing group
Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.
Sharp HealthCare
San Diego, California, United States
St. Vincent Gynecologic Oncology
Serologic Response (Change in CA125 Level)
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Time frame: Baseline to response (up to 30 weeks)
Serologic Response (Change in Cancer Antigen [CA-125] Level)
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Time frame: Baseline to response (up to 27 weeks)
Time to Serologic Response (Change in CA-125 Level)
Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.
Time frame: Baseline to response (up to 27 weeks)
Duration of Serologic Response (CA-125)
Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being \>2 X ULN on two occasions.
Time frame: Baseline to response (up to 44 months)
Overall Response Rate
The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, "complete response" (CR), "partial response" (PR), "stable disease" (SD), or "progressive disease" (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR.
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Indianapolis, Indiana, United States
Hematology and Oncology Specialists, LLC
Covington, Louisiana, United States
Jayne Gurtler, M.D.
Metairie, Louisiana, United States
Hematology and Oncology Specialists, LLC
Metarie, Louisiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Cooper University Hospital
Voorhees Township, New Jersey, United States
New York Oncology Hematology
Albany, New York, United States
...and 10 more locations
Time frame: Baseline to response (up to 44 months)
Progression-free Survival (PFS)
PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 \>2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.
Time frame: Baseline to response (up to 44 months)
Percentage of Participants Who Had a Prolongation of Remission
Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator's assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.
Time frame: Baseline to response (up to 44 months)