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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00277043
First Posted: January 13, 2006
Last Update Posted: September 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
  Purpose
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 Intervention Phase
Supportive Ill-defined Sites Drug: paclitaxel, docetaxel, taxane Drug: taxane Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: June 2002
Study Completion Date: September 2005
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00277043     History of Changes
Other Study ID Numbers: 0902C
First Submitted: January 11, 2006
First Posted: January 13, 2006
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