An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ovarian Cancer

In brief

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

Key facts

Study ID

NCT00738699

Run by

Morphotek

People needed

415

Starts

2008-09-01

Expected to finish

2012-01-01

Last updated by the study team

2017-03-30

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• California Cancer Care, Inc. — Greenbrae, California, United States
• Moores UC San Diego Cancer Center — La Jolla, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Monterey Bay Oncology — Monterey, California, United States
• Jupiter Medical Center — Jupiter, Florida, United States
• Innovative Medical Research of South Florida, Inc. — Miami, Florida, United States
• Florida Hospital Cancer Institute — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Central DuPage Hospital — Winfield, Illinois, United States
• St. Vincent Gynecologic Oncology — Indianapolis, Indiana, United States
• Hematology and Oncology Specialists, LLC — Metairie, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Weinberg Cancer Institute at Franklin Square — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Schwartz Gynecologic Oncology, PLLC — Brightwaters, New York, United States
• Arena Oncology Associates, PC — Lake Success, New York, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Piedmont Hematology Oncology Associates, PA — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Signal Point Clinical Research Center — Middletown, Ohio, United States
• Southern Cancer Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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