Using 9-Aminocampotothecin in Patients with Inoperable Epithelial Ovarian Cancer Who Have Had One Prior Chemotherapy Regimen, E9501 (A Phase II Trial)
New York Gynecologic Oncology Group and the Eastern Cooperative Oncology Group through the NCI-sponsored Cancer Cooperative Group Program
Purpose of the Study
To evaluate the effectiveness of an anti-cancer drug called 9-aminocampotothecin in treating people with inoperable epithelial ovarian cancer who had already been treated with platinum-based chemotherapy.
The use of 9-aminocamptothecin as an additional treatment after platinum-based chemotherapy was equally effective to standard-of-care drugs in patients with similar disease. In this study, 17 percent of patients who had already been treated for cancer responded; 22 percent of patients with measurable disease responded. Response to the treatment ranged from 4.6 to 78 months. These results are similar to other medications currently used to treat ovarian cancer in the “second-line setting” including paclitaxel, topotecan, and pegylated liposomal doxorubicin, but not superior to available agents.
The chemotherapy 9-Aminocamptothecin is still under investigation and is not generally available to treating physicians. This agent did not show sufficient promise to continue testing in the treatment of ovarian cancer, given the currently available treatments.
May 30, 1996
January 18, 2000
Number of Participating Patients
Patients must have been 18 years of age, have had a tumor that could be measured, and have received only one type of chemotherapy.
Patients received a three-day continuous infusion of 9-aminocamptothecin every two weeks as long as they showed a positive response, that is, either the tumor shrank or did not increase in size. Patients were followed until the disease progressed.
The most common side effects included a reduction in the production of red and white blood cells and platelets (80 percent), nausea (27 percent), vomiting (20 percent), fatigue (five percent), diarrhea (four percent), abdominal pain (five percent), and infection (eight percent).
Additional Information at ClinicalTrials.gov