The objectives of this study are to determine the response rate to 9-AC in patients with
advanced ovarian cancer who have recurrent disease after paclitaxel- and cisplatin-based
This is a Phase II study of 9-aminocamptothecin (9-AC), administered as an intravenous
continuous infusion over 72 hours with G-CSF support for patients with advanced refractory
ovarian cancer. The objectives of the present study are to determine the response rate to
9-AC in patients with advanced ovarian cancer who have recurrent disease after paclitaxel-
and cisplatin-based chemotherapy regimens.
Histologically proven, advanced epithelial ovarian cancer.
Histologic confirmation by Pathology Department, NIH, required.
Recurrent disease after paclitaxel and either cisplatin or carboplatin. Combination
Bidimensionally measurable disease on physical exam, radiographs, or peritoneoscopy.
Repeat peritoneoscopy after 8 courses of therapy required if documentation of disease was
solely by peritoneoscopy.
Laparotomy not required.
No CNS metastasis.
No borderline or mixed histology.
See Disease Characteristics.
More than 4 weeks since any prior therapy and recovered.
No prior camptothecin analogue-based chemotherapy.
No prior radiotherapy except intraperitoneal 32-P.
Age: 18 and over.
Performance status: ECOG 0-2.
WBC greater than 3,000.
AGC greater than 1,500.
Platelets at least 100,000.
Hemoglobin greater than 9 g/dL OR;
Hematocrit greater than 27 g/dL.
Bilirubin no greater than 1.5 mg/dL.
Serum transaminases no greater than 2 times normal.
24-hour creatinine clearance greater than 45 mL/min (documented by NCI investigator or
primary care physician).
No myocardial infarction within 12 months.
No active congestive heart failure.
No heart block.
No arrhythmia requiring medication.
No active uncontrolled infection.
No known HIV positivity.
No second malignancy currently under treatment except: Local basal cell carcinoma of the
skin, Cervical carcinoma in situ, Other malignancies (e.g., stage I breast cancer)
eligible at the discretion of the principal or associate investigators.
No pregnant women.