Status:
COMPLETED
A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
Lead Sponsor:
New Mexico Cancer Research Alliance
Conditions:
Supportive
Ill-defined Sites
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 progra...
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 le...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00277043
Start Date
June 1 2002
End Date
September 1 2005
Last Update
September 27 2011
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131