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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ovarian Neoplasms

Intervention / Treatment
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* Drug: 9-aminocamptothecin


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 9-aminocamptothecin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacodynamic Studies, Pharmacokinetics