Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
NCT ID: NCT00287859
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2004-08-31
2006-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Escalating Cohorts
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.
topotecan hydrochloride
intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
topotecan hydrochloride
intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Septicemia, severe infection, or acute hepatitis
* Severe gastrointestinal bleeding, defined as requiring a blood transfusion or hospitalization
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Masonic Cancer Center, University of Minnesota
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Levi S. Downs, MD
Role: STUDY_CHAIR
Masonic Cancer Center, University of Minnesota
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UMN-WCC-39
Identifier Type: OTHER
Identifier Source: secondary_id
2004LS039
Identifier Type: -
Identifier Source: org_study_id