Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer

NCT ID: NCT00004206

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30

Brief 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.

Detailed Description

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.

Conditions

Ovarian Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

FOLFOX regimen

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Leicester

OTHER

Sponsor Role: lead

Principal Investigators

Kenneth O'Byrne, MD

Role: STUDY_CHAIR

University Hospitals, Leicester

Locations

University Hospitals of Leicester

Leicester, England, United Kingdom

Countries

United Kingdom

Other Identifiers

LRI-IND.02-V3

Identifier Type: -

Identifier Source: secondary_id

EU-99036

Identifier Type: -

Identifier Source: secondary_id

CDR0000067452

Identifier Type: -

Identifier Source: org_study_id