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

NCT00277043 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-09-27

No results posted yet for this study

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.

Conditions

  • Supportive
  • Ill-defined Sites

Interventions

DRUG

paclitaxel, docetaxel, taxane

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.

DRUG

taxane

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.

Sponsors & Collaborators

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Ian Rabinowitz, MD · University of New Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2004-07-31
Completion
2005-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277043 on ClinicalTrials.gov