Defining an Exposure Target for Weekly Paclitaxel Infusion in Breast Cancer Patients

NCT02338115 | Completed DMC

• 1 other identifier: UMCC 2014.002
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective observational study is to understand the relationship between paclitaxel exposure and development of peripheral neuropathy during treatment.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Severe neuropathy

  Increase in sensory scale of PRO measure of 5 points or more

  During 12 cycles of paclitaxel treatment (12 weeks for most patients but longer for patients who have treatment delays. Expected maximum 16 weeks of treatment)

Study Arms (1)

Weekly paclitaxel treatment group

Breast cancer patients initiating paclitaxel 80mg/m2 weekly x 12 weeks for curative treatment will be followed prospectively for collection of samples and longitudinal neuropathy data.

Drug: Paclitaxel 80mg/m2 weekly x 12 weeks

Interventions

Paclitaxel 80mg/m2 weekly x 12 weeks DRUG

Also known as: Taxol

Weekly paclitaxel treatment group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients receiving weekly 1-hour paclitaxel infusions for curative treatment

You may qualify if:

• Diagnosis of invasive breast cancer
• Systemic treatment with paclitaxel for curative intent (neoadjuvant, adjuvant, or oligometastatic disease per PI discretion)
• mg/m2 1-hour infusions weekly for up to 12 weeks
• Female sex
• \>18 years old
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Distant metastatic disease
• Concurrent treatment with duloxetine or enrollment on clinical study of neuroprotective agent
• History of allergic reaction to paclitaxel or cremophor EL
• Current signs or symptoms of severe peripheral neuropathy
• Known family history of hereditary peripheral neuropathy or Charcot-Marie-Tooth disease
• Known current pregnancy

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum at end of first infusion and 24 hours after Whole blood prior to infusion, at end of infusion and 24 hours after, and every 3-4 weeks

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Daniel L Hertz, PharmD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: May 1, 2014
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-05

Locations

US (1)