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A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes

Sponsor
New Mexico Cancer Care Alliance (Other)
Overall Status
Completed
CT.gov ID
NCT00277043
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
39
Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study are to determine whether a test dose program for taxanes will reduce the rate and/or severity of hypersensitivity reactions (HSR); and to determine whether a test dose program for taxanes will result in cost reduction due to decreased drug wastage.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Patients will be randomized on to one of two arms:

  1. Test dose arm 1 mg paclitaxel or docetaxel test dose is prepared in 3 ml of normal saline and administered over two to five minutes IV push at least 30 minutes after prescribed IV and PO pre-medications. If no discernable adverse reaction ensues, the balance of the taxane dose is prepared and administered as per standard or specific chemotherapy protocol.

  2. Non test dose arm The full taxane dose is prepared and administered as per standard or specific chemotherapy protocol, at least 30 minutes after prescribed IV and PO pre-medications.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
Study Start Date :
Jun 1, 2002
Actual Primary Completion Date :
Jul 1, 2004
Actual Study Completion Date :
Sep 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1 Test Dose

Drug: paclitaxel, docetaxel, taxane
1 mg paclitaxel or docetaxel test dose is prepared in 3 ml of normal saline and administered over two to five minutes IV push at least 30 minutes after prescribed IV and PO pre-medications. If no discernable adverse reaction ensues, the balance of the taxane dose is prepared and administered as per standard or specific chemotherapy protocol.
Other Names:
  • Taxol
  • Taxotere

    		•
    Active Comparator: 2) Non test dose arm

    Drug: taxane
    The full taxane dose is prepared and administered as per standard or specific chemotherapy protocol, at least 30 minutes after prescribed IV and PO pre-medications.

    Outcome Measures

    Primary Outcome Measures

    1. Patient HSR severity will be graded with an integer from 1 to 5 using the National Cancer Institute's Common Toxicity Criteria (CTC) for allergy/immunology. All Grade 3-4 HSRs will be reported through the FDA's MedWatch program [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient must sign informed consent

    • Patient must be greater than 18 years of age

    • Patient must be receiving his/her first dose of either Taxol or Taxotere

    • Patient must have received routine premedications for hypersensitivity reactions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of New Mexico Albuquerque New Mexico United States 87131

    Sponsors and Collaborators

    • New Mexico Cancer Care Alliance

    Investigators

    • Principal Investigator: Ian Rabinowitz, MD, University of New Mexico

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    New Mexico Cancer Care Alliance
    ClinicalTrials.gov Identifier:
    NCT00277043
    Other Study ID Numbers:
    • 0902C
    First Posted:
    Jan 13, 2006
    Last Update Posted:
    Sep 27, 2011
    Last Verified:
    Dec 1, 2009
    Keywords provided by New Mexico Cancer Care Alliance
    Taxane
    Test Dose
    Additional relevant MeSH terms:
    Paclitaxel
    Docetaxel
    Taxane

    Study Results

    No Results Posted as of Sep 27, 2011