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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001427 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Neoplasms |
Drug: 9-aminocamptothecin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 1995 |
| Estimated Study Completion Date: | April 2000 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00001427 History of Changes |
| Other Study ID Numbers: | 950056, 95-C-0056 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
|
Pharmacodynamic Studies Pharmacokinetics |
|
Neoplasms Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders 9-amino-20-camptothecin Cisplatin Paclitaxel |
Camptothecin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
