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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01448759
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : April 24, 2015
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.

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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

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)

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT01448759

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

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Responsible Party: Institut Curie 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:
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Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action