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

NCT ID: NCT01481701

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ovarian Carcinoma Relapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intravenous chemotherapy

treatment of ovarian carcinoma in relapse

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

85 mg/m² / 14days

oxaliplatin

Intervention Type DRUG

oxaliplatin

Interventions

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Oxaliplatin

85 mg/m² / 14days

Intervention Type DRUG

oxaliplatin

oxaliplatin

Intervention Type DRUG

Other Intervention Names

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No other intervention

Eligibility Criteria

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Inclusion Criteria

* ovarian carcinoma relapse

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jules Bordet Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronique D'Hondt, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Locations

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Institut Jules Bordet

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Folfox

Identifier Type: -

Identifier Source: org_study_id

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