Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00287859
• Other study ID #: 2004LS039
• Secondary ID: UMN-WCC-39
• Status: Terminated
• Phase: Phase 1
• First received: February 6, 2006
• Last updated: November 27, 2017
• Start date: August 2004
• Est. completion date: December 2006

Study information

• Verified date: November 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have a poor performance status.

PURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer with a poor performance status.

Description:

OBJECTIVES:

Primary

• Determine the maximum tolerated dose of weekly topotecan in patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer and a poor performance status.

Secondary

• Estimate the response rate of women with poor performance status for use in future clinical trials.

OUTLINE: This is a dose-escalation study.

Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6 patients will be treated at the MTD.

Patients are followed periodically for up to 2 years.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histological diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer

• Progressive or recurrent disease

• Received = 1 prior course of chemotherapy

• Measurable or evaluable disease OR disease assessable by CA 125, defined as CA 125 > normal that has increased over 2 readings > 14 days apart

• Karnofsky performance status 10-50%

• Absolute neutrophil count = 1,500/mm^3

• Platelet count = 100,000/mm^3

• Creatinine = 1.5 mg/dL

• Alkaline phosphatase = 3 times upper limit of normal (ULN)

• Total bilirubin = 1.5 times ULN

• SGOT = 3 times ULN

• Life expectancy = 12 weeks

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use accepted and effective non-hormonal contraception

Exclusion Criteria:

• Other neoplasm within the past 5 years except for nonmetastatic, nonmelanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or chemotherapy

• Septicemia, severe infection, or acute hepatitis

• Severe gastrointestinal bleeding, defined as requiring a blood transfusion or hospitalization

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• topotecan hydrochloride
intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.

Locations

Country	Name	City	State
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose