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 - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	January 1995
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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 chemotherapy regimens.
Detailed Description	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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety/Efficacy Study
Condition ^ICMJE	Ovarian Neoplasms
Intervention ^ICMJE	Drug: 9-aminocamptothecin
Study Arms / Comparison Groups
Publications *	Burris HA, Rothenberg ML, Kuhn JG, Von Hoff DD. Clinical trials with the topoisomerase I inhibitors. Semin Oncol. 1992 Dec;19(6):663-9. Review. Fukuoka M, Niitani H, Suzuki A, Motomiya M, Hasegawa K, Nishiwaki Y, Kuriyama T, Ariyoshi Y, Negoro S, Masuda N, et al. A phase II study of CPT-11, a new derivative of camptothecin, for previously untreated non-small-cell lung cancer. J Clin Oncol. 1992 Jan;10(1):16-20.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	April 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001427
Responsible Party
Study ID Numbers ^ICMJE	950056, 95-C-0056
Study Sponsor ^ICMJE	National Cancer Institute (NCI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	January 2000
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP