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

A Non Randomized Stratified Phase II Trial Evaluating Efficacy and Safety of Oxaliplatin in Combination With 5-Fluorouracil in Patients With Platinum-sensitive and Platinum-resistant Recurrent Ovarian Carcinoma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01481701

Enrollment

Registered

2011-11-29

Start date

2008-10-31

Completion date

2014-05-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Carcinoma, Relapse

Keywords

ovarian carcinoma, Bordet, relapse

Brief summary

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

Detailed description

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.

Interventions

DRUGOxaliplatin

85 mg/m² / 14days

DRUGoxaliplatin

oxaliplatin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ovarian carcinoma relapse

Exclusion criteria

* neurotoxicity grade III renal clearance \< 60 ml/min

Design outcomes

Primary

Measure	Time frame
Objective response rate	at 4 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026