Clinical trial NCT00738699: An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Official title: A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab) in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: ovarian cancer
relapsed ovarian cancer
refractory ovarian cancer
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 415
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Clinical contraindications to use of paclitaxel, which include:

  1. persistent Grade 2 or greater peripheral neuropathy
  2. 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).

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Secondary outcomes:
measure: Best Overall Response
timeFrame: 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
measure: Time to Tumor Response (TTR)
timeFrame: 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
Other outcomes:
measure: Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)
timeFrame: Length of study
measure: Serologic Response Rate
timeFrame: Length of study
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: La Jolla
country: United States
facility: Moores UC San Diego Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Monterey
country: United States
facility: Monterey Bay Oncology
state: California
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Miami
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Gynecologic Oncology
state: Indiana
city: Metairie
country: United States
facility: Hematology and Oncology Specialists, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Weinberg Cancer Institute at Franklin Square
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Brightwaters
country: United States
facility: Schwartz Gynecologic Oncology, PLLC
state: New York
city: Lake Success
country: United States
facility: Arena Oncology Associates, PC
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Winston Salem
country: United States
facility: Piedmont Hematology Oncology Associates, PA
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center
state: Ohio
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Harlingen
country: United States
facility: International Beneficence Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology & Hematology PA
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital and Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Annandale
country: United States
facility: Northern Virginia Pelvic Surgery Associates
state: Virginia
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Toorak Gardens
country: Australia
facility: The Burnside War Memorial Hospital, Inc.
state: South Australia
city: East Bentleigh
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelburg
country: Australia
facility: Mercy Hospital for Women
state: Victoria
city: Parkville
country: Australia
facility: The Royal Women's Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Subiaco
country: Australia
facility: St. John of God Hospital
state: Western Australia
city: Kortrijk
country: Belgium
facility: AZ Greninge Hospital
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Liege
country: Belgium
facility: CHU de Liege
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer Agency
state: British Columbia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Groningen
country: Netherlands
facility: UMCG
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Palma de Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
state: Baleares
city: Palma de Mallorca
country: Spain
facility: Hospital de Son Llatzer
state: Baleares
city: Mataro
country: Spain
facility: Hospital de Mataro
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Taulis
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Alcorcon
country: Spain
facility: Fundacion Hospital Alcorcon
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References: