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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Carcinoma, Relapse

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Trial Information

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


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.


Inclusion Criteria:



- ovarian carcinoma relapse

Exclusion Criteria:

- neurotoxicity grade III renal clearance < 60 ml/min

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

at 4 years

Safety Issue:

No

Principal Investigator

Veronique D'Hondt, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jules Bordet Institute

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

Folfox

NCT ID:

NCT01481701

Start Date:

October 2008

Completion Date:

October 2013

Related Keywords:

  • Ovarian Carcinoma
  • Relapse
  • ovarian carcinoma
  • Bordet
  • relapse
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

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