A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma

Jules Bordet Institute90 enrolled

Overview

This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.

Evaluation of the safety and the efficacy of a combination of oxaliplatin and 5FU (Folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen. The Folfox regimen is administered every 14 days. Evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ovarian Carcinoma Relapse

Interventions

OxaliplatinDRUG

85 mg/m² / 14days

oxaliplatinDRUG

oxaliplatin

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ovarian carcinoma relapse Exclusion Criteria: * neurotoxicity grade III renal clearance \< 60 ml/min

Locations (1)

Institut Jules Bordet

Brussels, Belgium

Outcomes

Primary Outcomes

Objective response rate

Time frame: at 4 years

Data from ClinicalTrials.gov

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