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

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Topotecan

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