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


Phase 3
18 Years
N/A
Not Enrolling
Both
Supportive, Ill-defined Sites

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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 MexicoAlbuquerque, New Mexico  87131