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

Phase 3

Completed

• Conditions: Supportive; Ill-defined Sites
• Interventions: Drug: paclitaxel, docetaxel, taxane; Drug: taxane

• Registration Number: NCT00277043
• Lead Sponsor: New Mexico Cancer Care Alliance

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 program for taxanes will result in cost reduction due to decreased drug wastage.

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 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.

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2004-07
• Study Completion: 2005-09
• Study First Submitted: 2006-01-11
• Study First Submitted QC: 2006-01-11
• Study First Posted: 2006-01-13
• Status Verified: 2009-12
• Last Update Submitted: 2011-09-23
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Test Dose	paclitaxel, docetaxel, taxane	-
2) Non test dose arm	taxane	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States