A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer
I. Estimate the overall clinical response rate (complete and partial responses) in patients
with previously treated ovarian epithelial, primary peritoneal, or fallopian tube cancer
treated with oxaliplatin and topotecan.
II. Determine the toxic effects in patients treated with this regimen.
I. Estimate the time to progression and overall clinical response duration in patients
treated with this regimen.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
response to prior platinum therapy (resistant vs sensitive).
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously
on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical response rate (complete and partial response by RECIST and/or CA [cancer antigen] 125)
Montefiore Medical Center
United States: Food and Drug Administration
|Montefiore Medical Center||Bronx, New York 10467-2490|
|NYU Cancer Institute||New York, New York 10016|