An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
- Conditions
- Ovarian Cancer
- Interventions
- Registration Number
- NCT00738699
- Lead Sponsor
- Morphotek
- Brief Summary
The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003 (farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer
- Detailed Description
Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 415
- Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks prior to study entry
- Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically within 6 months of most recent platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.
- Must have been treated with debulking surgery and at least one line platinum-based chemotherapy;
- Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance.
- Subjects must be candidate for repeat paclitaxel treatment
-
Clinical contraindications to use of paclitaxel, which include:
- persistent Grade 2 or greater peripheral neuropathy
- prior hypersensitivity reaction that persisted despite rechallenge with or without desensitization or resulted in bronchospasm or hemodynamic instability or was at least Grade 2 and resulted in medication discontinuation
-
Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that has been surgically resected is acceptable provided the subject did
-
Prior radiation therapy is excluded with the exception that it is allowable only if measurable disease for ovarian cancer is completely outside the radiation portal
-
Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA).
-
Previous treatment with MORAb-003 (farletuzumab).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Paclitaxel MORAb-003 (Farletuzumab) Plus Paclitaxel 2 0.9% Saline Placebo Plus Paclitaxel 2 Paclitaxel Placebo Plus Paclitaxel 1 MORAb-003 (farletuzumab) MORAb-003 (Farletuzumab) Plus Paclitaxel
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
Overall Survival (OS) Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
- Secondary Outcome Measures
Name Time Method Best Overall Response Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).
Time to Tumor Response (TTR) Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.
Trial Locations
- Locations (61)
USC/Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Innovative Medical Research of South Florida, Inc.
🇺🇸Miami, Florida, United States
Weinberg Cancer Institute at Franklin Square
🇺🇸Baltimore, Maryland, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Magee-Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Piedmont Hematology Oncology Associates, PA
🇺🇸Winston Salem, North Carolina, United States
Monterey Bay Oncology
🇺🇸Monterey, California, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
St. John of God Hospital
🇦🇺Subiaco, Western Australia, Australia
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Northern Virginia Pelvic Surgery Associates
🇺🇸Annandale, Virginia, United States
Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Southern Cancer Center
🇺🇸Mobile, Alabama, United States
Moores UC San Diego Cancer Center
🇺🇸La Jolla, California, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
St. Vincent Gynecologic Oncology
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Hematology and Oncology Specialists, LLC
🇺🇸Metairie, Louisiana, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Schwartz Gynecologic Oncology, PLLC
🇺🇸Brightwaters, New York, United States
Signal Point Clinical Research Center
🇺🇸Middletown, Ohio, United States
Arena Oncology Associates, PC
🇺🇸Lake Success, New York, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
St. Luke's Roosevelt Hospital Center
🇺🇸New York, New York, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
International Beneficence Clinical Research, LLC
🇺🇸Harlingen, Texas, United States
South Texas Oncology & Hematology PA
🇺🇸San Antonio, Texas, United States
Scott & White Memorial Hospital and Clinic
🇺🇸Temple, Texas, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Royal Brisbane & Women's Hospital
🇦🇺Herston, Queensland, Australia
The Burnside War Memorial Hospital, Inc.
🇦🇺Toorak Gardens, South Australia, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Monash Medical Centre
🇦🇺East Bentleigh, Victoria, Australia
Mercy Hospital for Women
🇦🇺Heidelburg, Victoria, Australia
AZ Greninge Hospital
🇧🇪Kortrijk, Belgium
The Royal Women's Hospital
🇦🇺Parkville, Victoria, Australia
University Hospitals Leuven
🇧🇪Leuven, Belgium
CHU de Liege
🇧🇪Liege, Belgium
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
BC Cancer Agency
🇨🇦Kelowna, British Columbia, Canada
Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
UMCG
🇳🇱Groningen, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Hospital Universitario Son Dureta
🇪🇸Palma de Mallorca, Baleares, Spain
Hospital de Son Llatzer
🇪🇸Palma de Mallorca, Baleares, Spain
University Hospital Maastricht
🇳🇱Maastricht, Netherlands
Hospital de Mataro
🇪🇸Mataro, Barcelona, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Corporacio Sanitaria Parc Taulis
🇪🇸Sabadell, Barcelona, Spain
Fundacion Hospital Alcorcon
🇪🇸Alcorcon, Madrid, Spain
Hospital Clinic I Provincial
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States