University of New Mexico
Albuquerque, New Mexico, 87131, United States
Completed
NCT Number: NCT00277043
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
About this study
Patients will be randomized on to one of two arms:
- 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.
- 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
paclitaxel, docetaxel, taxane
Drug1 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
taxane
DrugThe 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.
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
New Mexico Cancer Research Alliance
Other
Registry information
Important dates
- Study start
- 2002
- Primary completion
- 2004
- Study completion
- 2005
- First posted
- Jan 13, 2006
- Registry last updated
- Sep 27, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.