Brief Title
Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Official Title
Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
Brief 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.
Detailed 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Maximum tolerated dose
Condition
Fallopian Tube Cancer
Intervention
topotecan hydrochloride
Study Arms / Comparison Groups
Escalating Cohorts
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
5
Start Date
August 2004
Completion Date
December 2006
Primary Completion Date
December 2006
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Levi S. Downs, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00287859
Organization ID
2004LS039
Secondary IDs
UMN-WCC-39
Study Sponsor
Masonic Cancer Center, University of Minnesota
Study Sponsor
Levi S. Downs, MD, Study Chair, Masonic Cancer Center, University of Minnesota
Verification Date
November 2017