Clinical and Biological Predictors of Chemotherapy Toxicity in Older Adults



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:65 - Any
Updated:5/10/2018
Start Date:September 9, 2011
End Date:April 2019

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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.

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.

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
We found this trial at
17
sites
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Mary Anne Fenton, MD
Phone: 401-444-5394
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Beverly Moy, MD, MPH
Phone: 617-724-1074
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Tracey O'Connor, MD
Phone: 716-845-4074
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: William Dale, MD
Phone: 773-834-0508
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Supriya Gupta Mohile, MD
Phone: 585-273-4150
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Rachel Freedman, MD
Phone: 617-632-4587
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Hyman Muss, MD
Phone: 919-843-1906
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Erika Ramsdale, MD
Phone: 434-297-7782
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Cynthia Owusu, MD
Phone: 216-844-7670
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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Duarte, California 91010
Principal Investigator: Arti Hurria, MD
Phone: 626-256-4673
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Cary Gross, MD
Phone: 203-688-8588
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Hyde Park, New York 11042
Principal Investigator: Myra Barginear, MD
Phone: 516-734-8745
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: William Tew, MD
Phone: 646-888-4220
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19111
Principal Investigator: Efrat Dotan, MD
Phone: 215-728-3545
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Andrew Chapman, DO
Phone: 215-955-8979
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Saint Louis, Missouri 63110
Principal Investigator: Tanya Wildes, MD
Phone: 314-747-8468
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Winston-Salem, North Carolina 27157
Principal Investigator: Heidi Klepin, MD
Phone: 336-713-6920
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