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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ClinicalTrials.gov Identifier: NCT00001427 |
Recruitment Status :
Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Neoplasms | Drug: 9-aminocamptothecin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
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 |
Study Start Date : | January 1995 |
Study Completion Date : | April 2000 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001427
United States, Maryland | |
National Cancer Institute (NCI) | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00001427 |
Other Study ID Numbers: |
950056 95-C-0056 |
First Posted: | December 10, 2002 Key Record Dates |
Last Update Posted: | March 4, 2008 |
Last Verified: | January 2000 |
Pharmacodynamic Studies Pharmacokinetics |
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders 9-aminocamptothecin Antineoplastic Agents |