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

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ClinicalTrials.gov Identifier: NCT01448759
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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

Condition or disease Intervention/treatment Phase
Tumors Other: blood sampling Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion
Study Start Date : October 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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.


Primary Outcome Measures :
  1. Evaluation of plasma alcohol [ Time Frame: One year ]
    Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448759


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

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT01448759     History of Changes
Other Study ID Numbers: IC 2011-03
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action