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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Institut Curie.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014