Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer
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|ClinicalTrials.gov Identifier: NCT00004206|
Recruitment Status : Unknown
Verified July 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 4, 2003
Last Update Posted : June 24, 2014
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin and fluorouracil in treating patients who have recurrent ovarian cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin||Phase 2|
OBJECTIVES: I. Determine the efficacy of oxaliplatin in combination with fluorouracil in terms of response rate, time to tumor progression, and overall survival in patients with recurrent ovarian cancer. II. Evaluate the safety profile of this combination regimen in this patient population.
OUTLINE: This is an open label study. Patients receive oxaliplatin IV over 2 hours once every 2 weeks and fluorouracil IV and leucovorin calcium IV once weekly. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease are followed at 1 month and at 3 months, then every 3 months for disease relapse and survival.
PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Oxaliplatin and 5 Fluorouracil in the Treatment of Advanced Ovarian Cancer|
|Study Start Date :||September 1999|
U.S. FDA Resources
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): NCT00004206
|University Hospitals of Leicester|
|Leicester, England, United Kingdom, LE1 5WW|
|Study Chair:||Kenneth O'Byrne, MD||University Hospitals, Leicester|