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

New Mexico Cancer Care Alliance

Status and phase: Completed; Phase 3

Conditions: Ill-defined Sites; Supportive

Treatments: Drug: paclitaxel, docetaxel, taxane; Drug: taxane

Study type: Interventional

Funder types: Other

Identifiers

NCT00277043

0902C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1 Test Dose

Experimental group

Treatment:

Drug: paclitaxel, docetaxel, taxane

2) Non test dose arm

Active Comparator group

Treatment:

Drug: taxane