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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

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
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005289-11-BE
Enrollment
90
Registered
2008-08-08
Start date
2008-10-08
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

ovarian carcinoma in relapse

Interventions

Trade Name: Eloxatin Product Name: Eloxatin Product Code: L01XAO3 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Eloxatin Current Sponsor code: oxaliplatin 1 Other des

Sponsors

Institut Jules Bordet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ovarian cancer recurrent disease first and later platinum-sensitive relapse second and later platinum-sensitive relapse Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: previous whole abdominal radiotherapy pregnancy unstable angina or myocardial infarction in the last six months severe hypersensitivity to platin compounds

Design outcomes

Primary

MeasureTime frame
Main Objective: to assess objective response rate ;Secondary Objective: to assess time to progression, overall survival ;Primary end point(s): objective response rate

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026