This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This is a phase-II single-arm trial studying the overall clinical response rate (complete response plus partial response [CR + PR]) and toxicities in women treated with oxaliplatin and continuous infusion topotecan. The primary objective is to estimate the overall clinical response rate(CR+PR) and toxicities in women treated with oxaliplatin and continuous-infusion topotecan when administered in combination every 4 weeks to patients with previously treated ovarian cancer. Patients who experience confirmed CR or PR by either RECIST and/or CA125 criteria will be classified as having a response. Secondary objectives are to estimate time to progression and overall clinical response duration in women treated with this regimen. Study endpoints are disease progression or completion of treatment. 27 subjects will be enrolled in stratum I, 25 in stratum II. Therapy will consist of a maximum of six four-week treatment cycles for a total treatment duration of 24 weeks. Treatment will be discontinued at disease progression. During treatment, disease response will be assessed after every two treatment cycles. It is hypothesized that the study treatment may provide slowing of disease progression or improvement in clinical response in patients with recurrent disease where prognosis is poor.
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