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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Supportive, Ill-defined Sites

Intervention / Treatment
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* Drug: paclitaxel, docetaxel, taxane
* Drug: taxane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Test Dose<br> | Drug: paclitaxel, docetaxel, taxane<br>* 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.<br>* Other names: Taxotere;|
| Active Comparator: 2) Non test dose arm<br> | Drug: taxane<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Taxane, Test Dose