Search / Trial NCT00001427

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Pharmacodynamic Studies Pharmacokinetics

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.

Gender

Female

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.

Attachments

readout_NCT00001427_2024-07-23.pdf

4.5 MB

NCT00001427_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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