NCT01481701

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

September 1, 2013

Enrollment Period

5.6 years

First QC Date

July 18, 2011

Last Update Submit

October 14, 2014

Conditions

Ovarian CarcinomaRelapse

Keywords

ovarian carcinomaBordetrelapse

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    at 4 years

Study Arms (1)

intravenous chemotherapy

EXPERIMENTAL

treatment of ovarian carcinoma in relapse

Drug: Oxaliplatin

Interventions

oxaliplatinDRUG

85 mg/m² / 14days

Also known as: No other intervention
intravenous chemotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ovarian carcinoma relapse

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Veronique D'Hondt, MD,PhD

    Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2011

First Posted

November 29, 2011

Study Start

October 1, 2008

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 15, 2014

Record last verified: 2013-09

Locations

BE(1)