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

Date de début de l'étude : 1 septembre 1998

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