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Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer



Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer

For Condition: recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): University Hospitals of Leicester ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed ovarian cancer - Must have received at least one prior platinum based chemotherapy regimen and have relapsed within 2 years of last chemotherapy regimen - Evaluable disease; Radiology confirmation AND/OR Elevated CA 125 (at least 60 IU/L) --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunotherapy - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy and recovered - Surgery: Not specified - Other: At least 30 days since prior investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) (unless documented Gilbert's syndrome); AST/ALT less than 3 times ULN (less than 5 times ULN if liver metastases present) - Renal: Creatinine normal - Cardiovascular: No unstable cardiovascular disease - Other: No active, uncontrolled infection; No other significant medical disorder or condition that would preclude study; No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
KennethO'Byrne,  Study Chair,  University Hospitals of Leicester

University Hospitals of Leicester
Leicester,  England,  LE1 5WW
United Kingdom
 


Additional Information:
Study ID Numbers:  CDR0000067452;  LRI-IND.02-V3,EU-99036
Study Start Date: September 1999
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004206

Other Recurrent Ovarian Epithelial Cancer Studies:
1. Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Persistent Ovarian Epithelial Cancer

2. Bryostatin 1 in Treating Patients With Ovarian Epithelial Cancer

3. Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer

4. Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer

5. Carboplatin With or Without Liposomal Doxorubicin in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

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Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer
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