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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00277043
First received: January 11, 2006
Last updated: September 23, 2011
Last verified: December 2009

January 11, 2006
September 23, 2011
June 2002
July 2004   (final data collection date for primary outcome measure)
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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00277043 on ClinicalTrials.gov Archive Site
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A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes

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.

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Supportive
  • Ill-defined Sites
  • 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
  • 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.
  • Experimental: 1 Test Dose
    Intervention: Drug: paclitaxel, docetaxel, taxane
  • Active Comparator: 2) Non test dose arm
    Intervention: Drug: taxane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2005
July 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00277043
0902C
Yes
New Mexico Cancer Care Alliance
New Mexico Cancer Care Alliance
Not Provided
Principal Investigator: Ian Rabinowitz, MD University of New Mexico
New Mexico Cancer Care Alliance
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP