This phase II trial is studying how well giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as oxaliplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Given IV
Given IV
NYU Cancer Institute
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125)
Tumor response was assessed every two cycles by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>= 30% decrease in the sum of the longest diameter (LD) of target lesions; Overall Response (OR) = CR + PR.
Time frame: Every two cycles for up to 24 weeks.
Time to Disease Progression by RECIST and/or CA 125
Time to disease progression by RECIST and/or CA 125
Time frame: Tumor measurements will be performed every 8 weeks until the date of first documented progression up to 100 weeks
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