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Phase II Study of Oxaliplatin and 5 Fluorouracil in the Treatment of Advanced Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

Phase II Study of Oxaliplatin and 5 Fluorouracil in the Treatment of Advanced Ovarian Cancer

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth O'Byrne, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospitals, Leicester


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms