A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic ovarian epithelial cancer that is platinum- and
paclitaxel resistant as defined by: Disease progression while on first-line regimen
containing both a platinum drug and paclitaxel OR Tumor progression within 6 months
of completion of platinum-based therapy (either as first- or second-line) or
paclitaxel-based therapy (either as first- or second-line)

- Refractory or recurrent ovarian epithelial cancer as defined by: Lesions of any
diameter

- Nonmeasurable disease (with CA-125 at least 35)

- Ascites and/or pleural effusions allowed

- No borderline or low malignant potential tumors

PATIENT CHARACTERISTICS:

- Age: 18 and over

- Performance status: Zubrod 0-2

- Life expectancy: At least 12 weeks

- WBC at least 3,000/mm3

- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3

- Bilirubin no greater than 1.5 mg/dL PT/PTT normal

- Creatinine no greater than 1.4 mg/dL

- No active, unresolved upper respiratory infections

- Not HIV positive

- At least 5 years since prior malignancy, except nonmelanomatous skin cancer

- Willing and able to undergo placement of Tenckhoff catheter in the peritoneal cavity
for sampling of ascites or peritoneal fluid

- No concurrent serious medical illness

- No untreated gastrointestinal obstruction

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- May have failed an unlimited number of prior chemotherapy regimens

- At least 30 days since prior chemotherapy

- No prior radiotherapy to the pelvis or abdomen

- Eligible for laparoscopy