Clinical Trial for Ovarian Cancer (OvaRex®) (NCT00050375) | Clinical Trial Compass
TerminatedPhase 3
Clinical Trial for Ovarian Cancer (OvaRex®)
Stopped: Study closed by sponser
United States354 participantsStarted 2002-12
Plain-language summary
This study will compare the time to disease relapse between OvaRex® MAb-B43.13-treated patients and placebo-treated patients. This study will also compare assessments of survival, quality of life, immune response and safety between active and placebo groups.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have a histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin, and their disease is classified as FIGO Stage III or IV. Histological diagnosis must have been confirmed by site pathology review of slides as documented by the site investigator. These slides must be made available for sponsor review.
* Patients must have had an elevated serum CA125 level (per reference lab normal range) measured prior to or at surgery (i.e., not later than the immediate post-surgery period when the patient is in the surgical recovery room). If a pre-surgical CA125 measurement is not available, then the patient must have had: (a) a serum CA125 level ≥100 U/mL, and (b) tumor tissue that has been demonstrated by immunohistochemical methods to express CA125.
* Patients must have had a documented serum CA125 level ≤65 U/mL prior to the third cycle of front-line chemotherapy.
* Patients must have had microscopic or small diameter residual disease following primary de-bulking surgical procedure.
* Patients must have received chemotherapy that included a platinum compound and a taxane following appropriate staging procedures. Front-line treatment can include no more than 8 cycles of chemotherapy.
* Patients must have had a complete clinical response to their front-line surgery and chemotherapy. A complete clinical response is defined as one in which the patient had a normal physical examination, no conclusive evidence of residual t…