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

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ClinicalTrials.gov Identifier: NCT00277043
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : September 27, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Supportive Ill-defined Sites Drug: paclitaxel, docetaxel, taxane Drug: taxane Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial Assessing the Utility of a Test Dose Program With Taxanes
Study Start Date : June 2002
Actual Primary Completion Date : July 2004
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Test Dose 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.
Other Names:
  • Taxol
  • Taxotere
Active Comparator: 2) Non test dose arm 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.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00277043


Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Ian Rabinowitz, MD University of New Mexico

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00277043     History of Changes
Other Study ID Numbers: 0902C
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: December 2009

Keywords provided by New Mexico Cancer Care Alliance:
Taxane
Test Dose

Additional relevant MeSH terms:
Paclitaxel
Docetaxel
Taxane
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action