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| ID | Type | Description | Link |
|---|---|---|---|
| 95-C-0056 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9-aminocamptothecin | Drug |
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1334279 | Background | Burris HA, Rothenberg ML, Kuhn JG, Von Hoff DD. Clinical trials with the topoisomerase I inhibitors. Semin Oncol. 1992 Dec;19(6):663-9. | |
| 1309380 | Background | 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. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C080125 | 9-aminocamptothecin |
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