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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001427
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 40
Study Start Date: January 1995
Estimated Study Completion Date: April 2000
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001427     History of Changes
Other Study ID Numbers: 950056
95-C-0056
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: January 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Pharmacodynamic Studies
Pharmacokinetics

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Camptothecin
9-aminocamptothecin
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors