Current as of December 07, 2023
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.
- 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.
- 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.
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
All reviews come from applied patients