A Phase II Trial of 72-Hour Continuous IV Infusion of 9-Aminocamptothecin With G-CSF Support in Patients With Advanced Ovarian Cancer Previously Treated With Paclitaxel and Cisplatin

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically proven, advanced epithelial ovarian cancer.
• • Histologic confirmation by Pathology Department, NIH, required.
• • Recurrent disease after paclitaxel and either cisplatin or carboplatin. Combination platinum/paclitaxel acceptable.
• • 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.
• PRIOR/CONCURRENT THERAPY:
• • 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.
• PATIENT CHARACTERISTICS:
• • Age: 18 and over.
• • Performance status: ECOG 0-2.
• Hematopoietic:
• • 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.
• Hepatic:
• • Bilirubin no greater than 1.5 mg/dL.
• • Serum transaminases no greater than 2 times normal.
• Renal:
• • 24-hour creatinine clearance greater than 45 mL/min (documented by NCI investigator or primary care physician).
• Cardiovascular:
• • No myocardial infarction within 12 months.
• • No active congestive heart failure.
• • No heart block.
• • No arrhythmia requiring medication.
• OTHER:
• • 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.