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

This study has been completed.
Information provided by (Responsible Party):
Institut Curie
ClinicalTrials.gov Identifier:
First received: October 6, 2011
Last updated: April 23, 2015
Last verified: April 2015
The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.

Condition Intervention
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:

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)

Enrollment: 30
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: February 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.

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

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01448759

Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Institut Curie
Principal Investigator: LE TOURNEAU Christophe, MD Institut Curie
  More Information

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: April 23, 2015
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:
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 30, 2016