Feasibility of performing chemoprevention trials in women at elevated risk of ovarian carcinoma: initial examination of celecoxib as a chemopreventive agent.
BACKGROUND: A pilot study was undertaken to determine the feasibility of examining a COX-2 inhibitor (Celecoxib) as a chemopreventive agent in women at increased risk of ovarian cancer undergoing risk reducing salpingoophorectomy. METHODS: Women at elevated inherited risk of ovarian carcinoma pursuing risk reducing salpingoophorectomy were eligible for this trial. Ten patients were assigned to a control group while 10 patients were administered Celecoxib (400 mg/day) for 3 months prior to surgery. Demographic data at enrollment was collected. Serum, urine, peritoneal fluid, and resected tissues were obtained for correlative laboratory study. Evaluation of serum VEGF alterations was examined using an ELISA-based assay. RESULTS: Enrollment of patients was completed in 16 months. Of 29 eligible patients, 20 enrolled onto the study. One patient from each group did not complete surgical intervention. No significant differences were observed in the enrollment characteristics between the groups. No occult cases of ovarian cancer were identified and no differences in the presence of follicular cyst, hemorrhagic cysts, or inclusion cysts were noted on initial pathologic review. While the mean serum VEGF levels obtained following the administration of a COX-2 inhibitor were lower than the pre-administration in 5 of 6 patients, statistical significance in this difference was not observed (P = 0.359). However, this is most likely due to the small number of serum samples available. CONCLUSION: These results would suggest that chemoprevention trials in ovarian cancer will be eagerly embraced by this patient population.