A Phase I Study of Ad-p53 (NSC# 683550) for Patients With Platinum- and Paclitaxel-Resistant Epithelial Ovarian Cancer
I. Determine the maximum tolerated doses of adenovirus p53 in patients with platinum- and
paclitaxel-resistant ovarian epithelial cancer.
II. Determine the qualitative and quantitative toxic effects of this regimen in these
III. Document the observed anti-tumor activity of this regimen in these patients.
IV. Evaluate the biological endpoints (e.g., induction of apoptosis, p53 expression) of this
regimen in these patients.
OUTLINE: This is a dose escalation study.
Patients undergo laparoscopy for p53 assessment and catheter placement. Patients receive
daily intraperitoneal injections of adenovirus p53 (Ad-p53) for 5 days every 3 weeks.
Treatment is repeated every 21 days in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients each are treated at each dose level of Ad-p53. The maximum
tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Judith K. Wolf, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|