Women with ovarian cancer who participate in clinical trials at this institution have improved survival compared with those who are treated with standard therapies. No other factors examined were associated with treatment completion or survival. Further, participation in clinical research does not vary by age, ethnicity, urban versus rural lifestyle, or cancer stage or histologic subtype. However, disclosure of this information to potential clinical trial participants may represent an ethical conflict and should be carefully considered in light of existing ethical guidelines for human subject research.

The aim of this study was to determine the feasibility of two treatment regimens for ovarian cancers: (1) combined intraperitoneal/intravenous (IP/IV) cisplatin/paclitaxel; or (2) IV only carboplatin/paclitaxel; both followed by 12 cycles of maintenance paclitaxel. A total of 102 subjects were identified who underwent surgery for stage III ovarian cancer. All subjects received either IV or IV/IP chemotherapy, and had a complete response. The subjects were then prescribed maintenance paclitaxel IV for an additional 12 months. Demographic and clinical data were analyzed. Forty-five subjects received combined IP/IV chemotherapy versus 57 who received IV therapy alone. IP/IV versus IV administration was not associated with differences in age, ethnicity, tumor histology, or incidence of intestinal surgery. Toxicities included fatigue, neuropathy, myelosuppression, and nausea/vomiting in both groups. In the IP/IV group, 29/47 subjects (61.7%) completed 12 cycles of maintenance paclitaxel versus 18/55 (32.7%) in the IV group (P = 0.006). The mean number completed by the IP/IV group was 8.6, while the IV group completed 5.8 cycles (P = 0.002). In subjects who received <12 cycles, the mean number of cycles completed by the IP/IV group was 3.1 versus 2.8 in the IV group. The reasons for stopping included neuropathy (33), fatigue (8), myelosuppression (7) and disease progression (6). Patients who received combined IP/IV chemotherapy were more likely to complete maintenance therapy than those who only received IV chemotherapy. Patients who stop maintenance therapy usually do so early in the course. Additional resources directed at physical and emotional support during early cycles of maintenance chemotherapy may allow more to complete the regimen.