Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy

Completed · Phase 2

Conditions studied: Ovarian Cancer

In brief

The purpose of this study is to determine whether the investigational drug catumaxomab delivered in the planned treatment schedule is a safe and effective treatment for women with advanced ovarian cancer who experience a complete response to chemotherapy.

Key facts

Study ID: NCT00377429
Run by: Neovii Biotech
People needed: 47
Starts: 2006-09-01
Expected to finish: 2008-02-01
Last updated by the study team: 2012-07-19

Who can join

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

You may qualify if…

Signed and dated informed consent form before any protocol-specific screening procedures
Histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stage IIb - IV
Optimal or sub-optimal cytoreductive surgery
Clinical complete response to platinum and taxane-based therapy consisting of at least four cycles, based on computed tomography (CT) scan and a CA-125 (cancer antigen 125) level below 35 U/mL
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Last dose of platinum and taxane-based therapy completed within 6 weeks prior to the start of catumaxomab treatment
Negative serum pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility)
Willingness of patients of childbearing potential to use an effective contraceptive method (i.e. oral contraceptive, cervical cap, diaphragm with spermicide, condom with spermicide, or intrauterine device) during the study and for at least 6 months after the last infusion

You may not qualify if…

Acute or chronic systemic infection
Exposure to chemotherapy, radiotherapy, immunotherapy or investigational anti-cancer therapy within 6 weeks of first dose of catumaxomab other than last regimen of platinum and taxane chemotherapy as outlined in protocol
Known human immunodeficiency virus (HIV) infection
Previous treatment with non-humanized murine (rat or mouse) monoclonal antibodies (mAb)
Inadequate renal function (creatinine > 1.5 x upper limit of normal [ULN])
Inadequate hepatic function:
Alanine aminotransferase (ALT) > 2.5 x ULN or
Aspartate aminotransferase (AST) > 2.5 x ULN or
Bilirubin > 1.5 x ULN
Platelets < 100,000 cells/mm\^3
Absolute neutrophil count (ANC) < 1,500 cells/mm\^3
History of myocardial infarction, congestive heart failure or relevant cardiac arrhythmia within the last 6 months
No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix if adequately treated
No history of brain metastases
Any further condition or disease that would, in the opinion of the Investigator, expose the patient to undue risk

Where it is running

Arizona Cancer Center — Tucson, Arizona, United States
Stanford University of Obstetrics and Gynecology — Stanford, California, United States
Florida Hospital Cancer Institute — Orlando, Florida, United States
Gynecologic Oncology - Hinsdale — Hinsdale, Illinois, United States
Michiana Hematology Oncology P.C. — South Bend, Indiana, United States
James Graham Brown Cancer Center — Louisville, Kentucky, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
University of New Mexico — Albuquerque, New Mexico, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Magee-Women Hospital of UPMC — Pittsburgh, Pennsylvania, United States
South Carolina Oncology Associates — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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