Status:
TERMINATED
Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 ma...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00287859
Start Date
August 1 2004
End Date
December 1 2006
Last Update
November 29 2017
Active Locations (1)
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1
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455