Intraperitoneal tgDCC-E1 and Intravenous Paclitaxel in Women With Platinum-Resistant Ovarian Cancer

Inclusion Criteria:

• Age greater than or equal to 18 years
• Recurrent epithelial ovarian cancer or primary peritoneal cancer with histologic confirmation of the original tumor. Recurrent disease may be manifested as an elevated CA-125 using the following criteria: (a) increase in CA-125 to at least 2x the upper limit of normal (assayed on 2 occasions at least 7 days apart) for subjects with a history of normal pre-treatment values or values that normalized with the most recent treatment - OR - (b) increase in CA-125 to 2x the lowest observed value on the most recent treatment (assayed on two occasions at least 7 days apart) for subjects whose CA-125 did not normalize with the most recent treatment.
• Platinum-resistant disease, defined as recurrence less than six months after discontinuation of treatment with platinum therapy or platinum-refractory disease defined as progression on a platinum-containing regimen.
• A treatment-free interval of at least three weeks for cytotoxic therapies, radiation therapy, or other experimental drugs prior to first treatment on this protocol.
• A Zubrod performance status of two or less.

Exclusion Criteria:

• Previous administration of tgDCC-E1A.
• Progression on any taxane-containing regimen, or recurrent within 6 months of receiving a weekly taxane-containing regimen.

Previous radiation to more than 25% of marrow-bearing areas.

• Any of the following laboratory values: Hemoglobin <9.0 gm/dl, ANC <1.5 K/ml, platelet <100 K/ml, creatinine >2 mg/dl, bilirubin >2 mg/dl, AST or ALT >2 times the upper limit of normal, or abnormal coagulation profiles (>2 seconds beyond upper range of normal PT or PTT).
• Known HIV-positive status or active systemic infection.
• History of other invasive malignancies, except for non-melanoma skin cancer, unless there is no evidence of other cancer within the past 5 years.
• Patients with grade 2 or greater neurotoxicity.
• Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction are eligible if their disease has been stable for the past six months. Patients with an ejection fraction under 40%.