Determination of Carboplatin's Optimal Plasmatic Exposure

March 17, 2009 updated by: Institut Claudius Regaud
To determine Carboplatin's optimal exposures(optimal AUCs)and parameters they depend on.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Centre Paul Papin
      • Bordeaux, France
        • Institut Bergonié
      • Evreux, France
        • Clinique Pasteur
      • Grenoble, France
        • CHU A. Michallon
      • Lille, France
        • Centre Oscar Lambert
      • Marseille, France
        • CHU de la Timone
      • Montpellier, France
        • Centre Val D'Aurelle
      • Nice, France
        • Centre Antoine Lacassagne
      • Nîmes, France
        • CHU de Nîmes
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Rouen, France
        • Clinique Mathilde
      • Saint Herblain (Nantes), France
        • Centre Rene Gauducheau
      • Toulouse, France
        • Institut Claudius Regaud
      • Toulouse, France
        • CHU de Toulouse Rangueil
      • Tours, France
        • CHRU Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Investigators

  • Principal Investigator: Laurence GLADIEFF, Doctor, Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

March 18, 2009

Last Update Submitted That Met QC Criteria

March 17, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04 GENE 05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neoplasms

Clinical Trials on Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe