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Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel (ALCOOTAX)

This study is currently recruiting participants.
Verified July 2011 by Institut Curie
Sponsor:
Information provided by (Responsible Party):
Institut Curie
ClinicalTrials.gov Identifier:
NCT01448759
First received: October 6, 2011
Last updated: October 10, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.


Condition Intervention
Tumors
 Other: blood sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Institut Curie:

Primary Outcome Measures:
  • Evaluation of plasma alcohol [ Time Frame: One year ] [ Designated as safety issue: No ]
    Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel)


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: blood sampling
    Other: Blood sampling 10mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.
Detailed Description:

In this study, there is no experimental treatment, or experimental care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chemotherapy with docetaxel or paclitaxel on an every 3-week schedule.
  • Patient with bitherapy are eligible only if the taxane is the first infusion.
  • All type of tumor.
  • Age>18 years old.
  • Signed written informed consent.

Exclusion Criteria:

  • Patient under 18.
  • Patient with bitherapy, if docetaxel or paclitaxel is not administered first.
  • Patient deprived of liberty.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448759

Contacts
Contact: MARAL Sylvie, UGEC Leader 0156245630 melanie.lebegue@curie.net

Locations
France
Institut Curie Recruiting
Paris, France, 75005
Contact: MARAL Sylvie, UGEC Leader     0156245630     melanie.lebegue@curie.net    
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: LE TOURNEAU Christophe, MD Institut Curie
  More Information

No publications provided

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01448759     History of Changes
Other Study ID Numbers: IC 2011-03
Study First Received: October 6, 2011
Last Updated: October 10, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Curie:
Patients receiving docetaxel or paclitaxel. All tumors.

Additional relevant MeSH terms:
Paclitaxel
Docetaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013