Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Neovii Biotech

Collaborator: Fresenius Biotech North America

Stanford Investigator(s):

Intervention(s):

  • Drug: catumaxomab

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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

Exclusion Criteria:

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Colleen Fitzsimmons
6507243155
Not Recruiting