Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy

Completed · Phase 2

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

In brief

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.

Key facts

Study ID

NCT00318370

Run by

Morphotek

People needed

58

Starts

2006-05-01

Expected to finish

2010-06-01

Last updated by the study team

2015-09-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female subjects at least 18 years of age, with a histologically confirmed diagnosis of non-mucinous epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) in first relapse after a first remission of 6 to 18 months duration.
• Subjects must have undergone surgery. Subjects must have received primary chemotherapy, including at least one platinum agent.
• Subject is eligible for retreatment with the same chemotherapy regimen that was used to induce remission (Exception: may reduce the dose of or discontinue taxane if contraindicated due to neurotoxicity.)
• CA125 must have been elevated prior to original chemotherapy.
• CA125 must be elevated at the time of relapse.
• Life expectancy greater than or equal to 6 months, as estimated by the investigator.
• Eastern Cooperative Oncology Group performance status of 0, 1 or 2
• Subjects must consent to use a medically acceptable method of contraception throughout the study period and for 28 days after final MORAb-003 administration, unless surgically sterile.
• Any significant concomitant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
• Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
• Absolute neutrophil count (ANC) ≥ 1.2 x 10e9/L
• Platelet count ≥ 100 x 10e9/L
• Hemoglobin ≥ 8 g/dL
• Subject must be willing and able to provide written informed consent. Translations of informed consent information may be provided, subject to the local institutional review board's (IRB's) policy.

You may not qualify if…

• Known central nervous system (CNS) tumor involvement.
• Evidence of other active malignancy requiring treatment.
• Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
• Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Exception: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).
• Active serious systemic disease, including active bacterial or fungal infection.
• Active hepatitis or HIV infection.
• Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, interleukin 1 receptor antagonist [IL-1RA] or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
• Treatment with a monoclonal antibody therapy AND have evidence of an immune or allergic reaction or documented HAHA.
• Maintenance of first remission by taxane or other chemotherapeutic agent(s).
• Initiation or planned initiation of cancer therapy not given to induce primary remission. Substitutions of agents materially similar to those used in the original regimen are permissible.
• Breast-feeding, pregnant, or likely to become pregnant during the study.

Where it is running

• Sharp HealthCare — San Diego, California, United States
• St. Vincent Gynecologic Oncology — 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
• Gabrail Cancer Center — Canton, Ohio, United States
• Lehigh Valley Women's Cancer Center — Allentown, Pennsylvania, United States
• Gynecology Oncology Research & Development — Greenville, South Carolina, United States
• Mary Crowley Medical Research Center — Dallas, Texas, United States
• South Texas Oncology & Hematology — San Antonio, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Northern Virginia Pelvic Surgery Associates — Annandale, Virginia, United States
• Peninsula Cancer Center — Newport News, Virginia, United States
• Krankenhaus Nordwest — Frankfurt, Germany
• Nationales Centrum fur Tumorerkrankungen — Heidelberg, Germany

Full record on ClinicalTrials.gov

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