Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by City of Hope Medical Center
Sponsor:
Collaborators:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01472094
First received: October 31, 2011
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

The goal of this study is to develop a "bedside to bench" model of clinical and biological predictors for toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast cancer. The investigators will develop a predictive model using clinical and biological predictors of toxicity to adjuvant and neoadjuvant chemotherapy in older adults with breast cancer. The investigators will also determine the association between clinical and biological factors and reduced relative dose intensity of the prescribed chemotherapy regimen. In addition, the investigators will explore specific chemotherapy toxicities associated with reduced relative dose intensity of a prescribed regimen.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Develop a predictive model of clinical and biological predictors for grade 2-5 toxicity to adjuvant and neoadjuvant chemotherapy. [ Time Frame: 6 months after completion of chemotherapy ] [ Designated as safety issue: No ]
  • Understand the association between clinical and biological factors and reduced relative dose intensity (RDI) of the prescribed chemotherapy regimen. [ Time Frame: 6 months after completion of chemotherapy ] [ Designated as safety issue: No ]
  • Identify the specific chemotherapy toxicities associated with reduced relative dose intensity of the prescribed chemotherapy regimen. [ Time Frame: 6 months after completion of chemotherapy ] [ Designated as safety issue: No ]
  • Understand the association between the receipt of adjuvant chemotherapy and change in functional status from pre-chemotherapy to end of chemotherapy. [ Time Frame: 6 months after completion of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess potential biomarkers for physiologic age, including interleukin-6, C-reactive protein, D-dimer, and p16 expression. [ Time Frame: 6 months after completion of chemotherapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 700
Study Start Date: September 2011
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
All patients 65 years old with Stage I to III breast cancer who are beginning adjuvant or neo-adjuvant chemotherapy.

Detailed Description:

Although cancer is a disease associated with aging, there is no standard tool in oncology practice that incorporates clinical and biological factors to identify older adults with cancer who may be more vulnerable to the toxicity of chemotherapy. It is generally recognized that chronological age tells relatively little about an older adult's physiological age. Oncologists allude to this when they describe an older adult as: "a 'young' 80-year-old" or "an 'old' 80-year-old," implying factors other than age contribute to the health status of an older adult. Geriatricians address this by routinely performing a "geriatric assessment," which measures independent clinical predictors of morbidity and mortality in older adults. In addition, several potential biomarkers of aging have been described that are associated with functional decline and mortality among older adults. This study will identify whether novel biomarkers of aging can predict risk of chemotherapy toxicity. The current proposal will fill this knowledge gap by melding the principles of geriatrics with those of oncology to create a tool to assess the clinical and biological risk factors for chemotherapy toxicity in older adults.

Furthermore, this study will determine the association between chemotherapy toxicity and dose reductions and/or delays that decrease chemotherapy dose intensity. Maintenance of chemotherapy dose intensity is necessary to maintain chemotherapy efficacy. Older adults are at risk for chemotherapy toxicity and if this toxicity results in decreased dose intensity, the benefits of chemotherapy will be compromised. This study will identify the association between clinical and biological predictors of grade 2-5 toxicity and relative dose intensity. Furthermore, this study will identify the specific dose-limiting toxicities. These data will provide evidence-based criteria to identify those patients whose projected risk of toxicity would limit dose intensity and compromise the efficacy of standard treatment. These data could serve as the basis for "vulnerable elderly trials" which would study an alternate therapy regimen in patients who are predicted to have a significant risk of toxicity (and compromised efficacy) with the standard regimen.

This proposal unites the fields of geriatrics and oncology, incorporating geriatric correlates of vulnerability and studying their impact in an aging oncology population. These data will be used to develop a predictive equation for the risk of chemotherapy toxicity that can be utilized in daily oncology practice. These data will facilitate decision-making regarding the risks and benefits of adjuvant chemotherapy in older adults with breast cancer and ultimately serve as a foundation on which to identify older adults at risk for chemotherapy toxicity in order to guide interventions to decrease this risk.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Outpatient clinic practices (City of Hope, Memorial Sloan-Kettering Cancer Center, Yale University School of Medicine, University of Rochester, University of North Carolina, Wake Forest University, and Case Western Reserve University)

Criteria

Patients with Breast Cancer:

Inclusion Criteria:

  • Patients with stages I-III breast cancer receiving adjuvant or neoadjuvant chemotherapy
  • Able to understand English
  • Able to provide informed consent
  • Patients age ≥65 and of any performance status are eligible

Exclusion Criteria:

  • Patients with metastatic disease

Breast Cancer Controls:

Inclusion Criteria:

  • Patients with stages I-III breast cancer
  • Patient will not receive adjuvant or neoadjuvant chemotherapy
  • Patients age ≥65 and of any performance status are eligible
  • Able to understand English
  • Able to provide informed consent

Exclusion Criteria:

  • Patients with metastatic disease
  • Receipt of chemotherapy

Healthy Controls:

Inclusion Criteria:

  • Patients age ≥65 and of any performance status are eligible
  • No history of cancer (excluding non-melanoma skin cancer)
  • Able to understand English
  • Able to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472094

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Arti Hurria, MD    626-256-4673 ext 68218    ahurria@coh.org   
Principal Investigator: Arti Hurria, MD         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06510
Contact: Cary Gross, MD    203-688-8588    cary.gross@yale.edu   
Principal Investigator: Cary Gross, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Tracey O'Connor, MD    716-845-4074    Tracey.O'Connor@roswellpark.org   
Principal Investigator: Tracey O'Connor, MD         
Hofstra-North-LIJ Cancer Institute Recruiting
New Hyde Park, New York, United States, 11042
Contact: Myra Barginear, MD    516-734-8745    mbarginear@NSHS.edu   
Principal Investigator: Myra Barginear, MD         
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: William Tew, MD    646-888-4220    teww@MSKCC.org   
Principal Investigator: William Tew, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Supriya Mohile, MD    585-273-4150    Supriya_Mohile@URMC.Rochester.edu   
Principal Investigator: Supriya Gupta Mohile, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Hyman Muss, MD    919-843-1906    hyman_muss@med.unc.edu   
Principal Investigator: Hyman Muss, MD         
Principal Investigator: Norman Sharpless, MD         
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27106
Contact: Heidi Klepin, MD    336-713-6920    hklepin@wakehealth.edu   
Principal Investigator: Heidi Klepin, MD         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Cynthia Owusu, MD, MS    216-844-7670    Cynthia.Owusu@case.edu   
Principal Investigator: Cynthia Owusu, MD         
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia,, Pennsylvania, United States, 19107
Contact: Andrew Chapman, DO    215-955-8979    Andrew.chapman@jefferson.edu   
Principal Investigator: Andrew Chapman, DO         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Arti Hurria, MD City of Hope Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01472094     History of Changes
Other Study ID Numbers: 11127, 1R01AG037037-01
Study First Received: October 31, 2011
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014