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

Free University of Brussels (ULB)

Status and phase: Completed; Phase 2

Conditions: Relapse; Ovarian Carcinoma

Treatments: Drug: oxaliplatin; Drug: Oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01481701

Folfox

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ovarian carcinoma relapse

Exclusion criteria

• neurotoxicity grade III renal clearance < 60 ml/min

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

intravenous chemotherapy

Experimental group

Description:

treatment of ovarian carcinoma in relapse

Treatment:

Drug: Oxaliplatin