Determination of Carboplatin's Optimal Plasmatic Exposure | NCT00145028

Studies
Determination of Carboplatin's Optimal Plasmatic Exposure

NCT00145028

Sponsor

Institut Claudius Regaud

Status

Completed

Last Update Posted

Mar 18, 2009Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Neoplasms

Interventions

Carboplatin

Countries

France

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

Mar 2009

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

May 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Feb 2009Actual

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 2005Estimated

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

Mar 17, 2009

Last Update Posted Date

Mar 18, 2009Estimated

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

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Name	Type	Description	Arm Group Labels	Other Names
Carboplatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine Carboplatin's optimal exposures (optimal AUCs) and parameters they depend on.

Secondary Outcomes

Measure	Description	Time Frame
To assign a standardization method for Carboplatin doses's calculation in chemotherapy's protocol including this drug.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Carcinoma histologically proved and which must be treated by Carboplatin, excepted weekly administered Carboplatin treatments
Age > 18 years
Neutrophils > 1500/mm3, blood-platelets > 100000/mm3
Patient with intravenous administration route for chemotherapy independent of the one used for blood samples ( for Investigators centers achieving pharmacokinetic examination)
Well-informed written consent, signed by the patient

Exclusion Criteria:

Carboplatin treatment's contra-indication
Patient with clinically detectable cerebral metastasis
Pregnant or nursing women
Patient under guardianship or trusteeship
Patient whose venous status don't permit a peripheral intravenous administration route's placing (for Investigators centers achieving pharmacokinetic examination)

Accepts Healthy Volunteers

Sex

All

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
Laurence GLADIEFF, Doctor	Institut Claudius Regaud	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Paul Papin		Angers			France
Institut Bergonié

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016190	Carboplatin

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided