Safety and Efficacy Study of Panzem® Nanocrystal Colloidal Dispersion in Patients With Ovarian Cancer

Inclusion criteria

• Written informed consent and HIPAA authorization for release of protected health information.
• Have histologically-confirmed:

• epithelial ovarian cancer or
• primary peritoneal carcinomatosis or
• fallopian tube cancer. Enrollment of patients with clear cell histology is encouraged.
• Have measurable disease according to RECIST or detectable disease by 1) CA-125 at least twice the ULN within 14 days prior to registration for protocol therapy; 2) Ascites and/or pleural effusion attributed to tumor; 3) solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definitions for target lesions. Radiographic assessments must be obtained within 28 days prior to registration for protocol therapy.
• Be 18 years of age or older at the time of consent.
• Be at least 4 weeks since last anti-cancer treatment, radiation or surgery at the time of registration for protocol therapy (with the exception of hormonal therapy, where a 1 week wash-out period is sufficient; minor surgeries, such as catheter placement or removal within 1 week from enrollment are allowed).
• Have failed at least one prior platinum based chemotherapeutic regimen. (Platinum failure is defined as Platinum-refractory (progression while receiving a platinum-containing regimen) or platinum-resistant (disease progression within 6 months from completion of platinum-containing regimen).
• Have life expectancy of at least 3 months.
• Have ECOG performance status of 0 or 1 as assessed within 14 days prior to registration for protocol therapy.
• Have near-normal organ function, as evidenced by laboratory data within 14 days prior to registration for protocol therapy:

• Aspartate aminotransferase and alanine aminotransferase less than 2.5 times upper limit of normal (ULN)
• Total bilirubin less than 1.5 times ULN
• Alkaline phosphatase less than 2.5 times ULN
• Absolute neutrophil count greater than or equal to 1,500 cells/mm3
• White blood cell count greater than or equal to 3,000 cells/mm3
• Hemoglobin greater than or equal to 9.0 g/dL
• Platelets greater than 75,000/mm3
• Creatinine levels less than 1.5 times ULN
• Have no evidence of bowel obstruction, malabsorption, or other contraindication to oral medication.
• Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of childbearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

Exclusion criteria

• Be breastfeeding.
• Have any condition that is likely to interfere with regular follow-up.
• Have a history of myocardial infarction or angina pectoris or angina equivalent within 6 months prior to registration for protocol therapy (the patient may be on anti-anginal medications if the symptoms can be entirely controlled), or have uncontrolled hypertension or congestive heart failure.
• Have participated in any clinical trial involving conventional or investigational drugs or devices within 4 weeks prior to registration for protocol therapy.
• Have had any active cancer in addition to the epithelial ovarian cancer within the last 5 years, with the exception of:

• superficial skin cancer (basal cell or squamous cell skin carcinoma)
• carcinoma in situ of the cervix
• Stage I endometrial cancer with less than 50% invasion of the myometrium, or
• other adequately treated Stage I or II cancer in complete remission.
• Have an active infection requiring antibiotic treatment.
• Be receiving concurrent anticoagulation therapy (low dose coumadin for port-a-cath maintenance is allowed).
• Have any additional uncontrolled serious medical condition or psychiatric illness.
• Be receiving combination anti-retroviral therapy for the treatment of immunodeficiency.
• Have brain metastases