CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9 enrolled
Drug / intervention
Standard of Care: Docetaxel +2 moredrug
Likely dose
Standard of Care: Docetaxel 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02502864
NCT02502864Phase 4Completed
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Multicenter Study Investigating Utilization of Pharmacokinetic(PK)-Guided Docetaxel in Senior Adult Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jul 20, 2015·Updated Sep 11, 2020

In Brief

A Phase 4 clinical trial evaluating Standard of Care: Docetaxel, Standard of Care: Cyclophosphamide, and 1 other intervention for Breast Cancer and Breast Cancer Female. Completed, enrolled 9 participants across 1 site.

Detailed Summary

The purpose of this study is to adjust the amount of docetaxel participants receive based on the level of docetaxel measured in their blood. This method of dose adjustment is called pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of docetaxel using this method will lessen the side effects associated with docetaxel in cancer treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Cancer Female
CountriesUnited States
CollaboratorsSaladax Biomedical, Inc.

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 20, 2015
Enrollment StartFeb 9, 2016
Primary CompletionSep 29, 2017
Study CompletionJan 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.0 years ago

Interventions

Standard of Care: Docetaxeldrug

Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m\^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.

Standard of Care: Cyclophosphamidedrug

Cycle 1: 600 mg/m\^2, via IV on Day 1 for 30 minutes. The cyclophosphamide dose will not be changed unless dictated by toxicity.

Function Assessment of Cancer Therapy (FACT) Surveysother

Participants will complete the FACT-Taxane and FACT-Breast quality of life assessment written surveys at baseline, during each chemotherapy cycle, and 3-5 weeks following the last cycle in which PK monitoring was performed.