A Trial Evaluating Efficacy and Safety of Oxaliplatin Wit... | NCT01481701

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

NCT01481701

Sponsor

Jules Bordet Institute

Status

Completed

Last Update Posted

Oct 15, 2014Estimated

Enrollment

90Estimated

Phase

Phase 2

Conditions

Ovarian Carcinoma
Relapse

Interventions

Oxaliplatin
oxaliplatin

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Jul 18, 2011

First Submission Date that Met QC Criteria

Nov 25, 2011

First Posted Date

Nov 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intravenous chemotherapy	Experimental	treatment of ovarian carcinoma in relapse	Drug: Oxaliplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug	85 mg/m² / 14days	intravenous chemotherapy	No other intervention

Measure	Description	Time Frame
Objective response rate		at 4 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ovarian carcinoma relapse

Exclusion Criteria:

neurotoxicity grade III renal clearance < 60 ml/min

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Veronique D'Hondt, MD,PhD	Jules Bordet Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Jules Bordet		Brussels		1000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms
D012008	Recurrence

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided