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

NCT ID: NCT00277043

Last Updated: 2011-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Supportive Ill-defined Sites

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 Test Dose

Group Type EXPERIMENTAL

paclitaxel, docetaxel, taxane

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

taxane

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Taxol Taxotere

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Mexico Cancer Research Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian Rabinowitz, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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0902C

Identifier Type: -

Identifier Source: org_study_id