Oxaliplatin and Topotecan in Advance Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00313612|
Recruitment Status : Terminated
First Posted : April 12, 2006
Results First Posted : November 27, 2015
Last Update Posted : November 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Ovarian Epithelial Cancer||Drug: oxaliplatin Drug: topotecan||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||December 2012|
Experimental: Treatment (oxaliplatin plus topotecan)
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.
- Clinical Response Rate (Complete and Partial Response by RECIST and/or CA [Cancer Antigen] 125) [ Time Frame: Every two cycles for up to 24 weeks. ]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 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 ]Time to disease progression by RECIST and/or CA 125
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313612
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|NYU Cancer Institute|
|New York, New York, United States, 10016|
|Principal Investigator:||Amy Tiersten||Montefiore Medical Center|