
    drug manufacturing issues
  
['ovarian cancer']
['fermented wheat germ extract (fwge)', 'placebo']

        Inclusion Criteria:

          -  Women with suspected epithelial ovarian, fallopian tube or primary peritoneal
             carcinoma scheduled to undergo surgical exploration with no prior treatment for the
             cancer. Signs of ovarian cancer include, but are not limited to: an elevated cancer
             antigen 125 (CA-125), a complex pelvic mass, ascites, and carcinomatosis. These signs
             are not necessary for suspicion or enrollment in this protocol.

          -  Age > 18 years and competent to give informed consent.

          -  Must have a Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1, or 2
             and a life-expectancy of at least 60 days.

          -  Adequate bone marrow function.

          -  Adequate renal function.

          -  Adequate hepatic function.

          -  Participants must sign an approved informed consent and authorization permitting
             release of personal health information.

          -  Women of childbearing potential must have a negative serum pregnancy test prior to the
             study entry and be practicing an effective method of birth control during the course
             of the study, in a manner such that risk of failure is minimized.

        Exclusion Criteria:

          -  Current use of FWGE

          -  Known allergy to wheat, rice (contained in the placebo), orange or the sweetener,
             Stevia.

          -  Potential participants who received neoadjuvant chemotherapy for ovarian cancer.

          -  An upper gastrointestinal or other condition that would impair swallowing or
             absorption of oral medication.

          -  Any serious illness or medical condition that would not permit the patient to be
             managed according to the protocol, including, but not to limited, any the following:
             History of significant neurologic or psychiatric disorder (e.g., uncontrolled
             psychiatric disorders) that would impair the ability to obtain consent or limit
             compliance with study requirement; Active uncontrolled or serious infection; Active
             peptic ulcer disease.

          -  Uncontrolled hypertension defined as systolic greater than 180 and diastolic greater
             than 100.
      