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

Inclusion Criteria

• •1. Written informed consent and HIPAA authorization for release of protected health information.
• •2. Have histologically-confirmed:
• •* epithelial ovarian cancer or
• •* primary peritoneal carcinomatosis or
• •* fallopian tube cancer. Enrollment of patients with clear cell histology is encouraged.
• •3. 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.
• •4. Be 18 years of age or older at the time of consent.
• •5. 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).
• •6. 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).
• •7. Have life expectancy of at least 3 months.
• •8. Have ECOG performance status of 0 or 1 as assessed within 14 days prior to registration for protocol therapy.
• •9. 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
• •10. Have no evidence of bowel obstruction, malabsorption, or other contraindication to oral medication.
• •11. 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.
• •12. 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.