Study Of Intraperitoneal EGEN-001 Administered In Combination With Pegylated Liposomal-Doxorubicin In Patients With Recurrent Or Persistent Epithelial Ovarian, Fallopian Tube Or Peritoneal Cancer

Inclusion Criteria:

- Histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal
carcinoma which is now recurrent.

- Patients with the following histologic epithelial cell types are eligible: High grade
serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear
cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise
specified (N.O.S.).

- Must have recurrence documented by elevated CA-125 (biochemical recurrence) or
clinically evident measurable or non-measurable recurrent disease.

- Must have adequate bone marrow, renal, hepatic, cardiac, neurologic function (as
defined in protocol), and absolute neutrophil count greater than or to 1,500/mcl.

- Must have recovered from effects of recent surgery, radiotherapy, or chemotherapy.

- Must have had one prior platinum-based chemotherapeutic regimen for management of
primary disease containing carboplatin, cisplatin, or another organoplatinum
compound.

- Must have a GOG performance status of 0 or 1.

- Patients of childbearing potential must have a negative pregnancy test prior to the
study entry and be practicing an effective form of contraception. If applicable,
patients must discontinue breastfeeding prior to study entry.

- Must meet the pre-entry requirements.

- Must sign an IRB-approved informed consent and authorization permitting release of
personal health information.

Exclusion Criteria:

- Prior treatment with EGEN-001.

- Prior treatment with PLD, doxorubicin, or other anthracyclines.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to EGEN-001 or other agents used in this study.

- Oral or parenteral corticosteroids within 2 weeks of study entry or a clinical
requirement for ongoing systemic immunosuppressive therapy.

- Receiving treatment for active autoimmune disease.

- Other invasive malignancies, with the exception of non-melanoma skin cancer and other
specific malignancies as noted in Sections 3.27 and 3.28 of the protocol if there is
any evidence of other malignancy being present within the last three years.

- If previous cancer treatment contraindicates this protocol therapy.

- Prior radiotherapy to any portion of the abdominal cavity or pelvis, however prior
radiation for localized cancer of the breast, head and neck, or skin is permitted,
provided that it was completed more than three years prior to registration, and the
patient remains free of recurrent or metastatic disease.

- Prior chemotherapy for any abdominal or pelvic tumor (other than ovarian, fallopian
tube and primary peritoneal). Patients may have received prior adjuvant chemotherapy
for localized breast cancer, provided that it was completed more than three years
prior to registration, and that the patient remains free of recurrent or metastatic
disease.

- Known active hepatitis.

- Concurrent severe medical problems unrelated to the malignancy that would
significantly limit full compliance with the study or expose the patient to extreme
risk or decreased life expectancy.

- Patients of childbearing potential, not practicing adequate contraception, patients
who are pregnant, or patients who are breastfeeding.

- History or evidence upon physical examination of CNS disease, including primary brain
tumor, seizures not controlled with standard medical therapy, any brain metastases,
or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA)
or subarachnoid hemorrhage within six months of the first date of treatment on this
study.

- Clinically significant cardiovascular disease.

- Any condition/anomaly that would interfere with the appropriate placement of the IP
catheter for study drug administration.