Overview

Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Leicester
Treatments:
Calcium
Fluorouracil
Leucovorin
Levoleucovorin
Oxaliplatin
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)

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

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