Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Trial Information
Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Safety Issue:
Yes
Principal Investigator
Levi S. Downs, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Food and Drug Administration
Study ID:
2004LS039
NCT ID:
NCT00287859
Start Date:
August 2004
Completion Date:
December 2006
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Peritoneal Cavity Cancer
- fallopian tube cancer
- peritoneal cavity cancer
- recurrent ovarian epithelial cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
