Title

Using 9-Aminocampotothecin in Patients with Inoperable Epithelial Ovarian Cancer Who Have Had One Prior Chemotherapy Regimen, E9501 (A Phase II Trial)

Sponsor

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.

Results

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.

Conclusion

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.

Start Date

May 30, 1996

Stop Date

January 18, 2000

Number of Participating Patients

60

Eligibility Requirements

Patients must have been 18 years of age, have had a tumor that could be measured, and have received only one type of chemotherapy.

Study Design

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.

Side Effects

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).

References

Hochster H, Plimack ER, Runowicz C, Speyer JL, Wallach RC, Sorich J, Mandeli J, Wadler S, Wright J, Muggia FM. Biweekly 72-hour 9-Aminocamptothecin Infusion as Second-Line Therapy for Ovarian Carcinoma: Phase II Study of the New York Gynecologic Oncology Group and the Eastern Cooperative Oncology Group. J Clin Oncol 2004 Jan 1;22(1):120-6. (E9501) [Manuscript]

National Cancer Institute Patient Summary

http://www.cancer.gov/clinical_trials/view_clinicaltrials.aspx?version=patient&cdrid=64290

Reviewed by

Howard S. Hochster, MD, New York University Cancer Institute; Cheryl K. Rutledge, BSN, Indiana University Cancer Center; Mary Lou Smith, ECOG Patient Representative

Released July 5, 2005 (Revised July 12, 2006)