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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

Primary Purpose

Ovarian Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
9-aminocamptothecin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring Pharmacodynamic Studies, Pharmacokinetics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001427
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms
Keywords
Pharmacodynamic Studies, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
9-aminocamptothecin

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1334279
Citation
Burris HA, Rothenberg ML, Kuhn JG, Von Hoff DD. Clinical trials with the topoisomerase I inhibitors. Semin Oncol. 1992 Dec;19(6):663-9.
Results Reference
background
PubMed Identifier
1309380
Citation
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. doi: 10.1200/JCO.1992.10.1.16.
Results Reference
background

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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

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