A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
18 Years
N/A
Both
Supportive, Ill-defined Sites
Trial Information
A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Ian Rabinowitz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of New Mexico
Authority:
United States: Institutional Review Board
Study ID:
0902C
NCT ID:
NCT00277043
Start Date:
June 2002
Completion Date:
September 2005
Related Keywords:
- Supportive
- Ill-defined Sites
- Taxane
- Test Dose
Name | Location |
|---|---|
| University of New Mexico | Albuquerque, New Mexico 87131 |
