Investigation of Genetic Determinants of Capecitabine Toxicity
This study is currently recruiting participants.
Verified August 2012 by University of Chicago
Sponsor:
University of Chicago
Collaborators:
Translational Breast Cancer Reserach Consortium
Information provided by (Responsible Party):
Peter O' Donnell, University of Chicago
ClinicalTrials.gov Identifier:
NCT00977119
First received: September 14, 2009
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia).
Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: Side-effect questionnaires Other: research blood samples |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Investigation of Genetic Determinants of Capecitabine Toxicity |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Capecitabine
U.S. FDA Resources
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Genetic variants of toxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to toxicity based on genetics [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Multiple genetic variants as predictors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Genome-wide association (potential) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Correlative sample collection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood (including DNA)
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Capecitabine
Women with breast cancer receiving capecitabine as treatment for their breast cancer.
|
Other: Side-effect questionnaires
Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
Other: research blood samples
Blood samples for research on DNA before starting treatment and after 4 cycles of treatment
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients receiving treatment with capecitabine for breast cancer at a participating academic medical center.
Criteria
Inclusion Criteria:
- women with breast cancer in whom single agent capecitabine therapy is being considered
- aged 18 years and older
Exclusion Criteria:
- patients who have previously received capecitabine are excluded
- patients cannot be receiving capecitabine in combination with another cancer chemotherapy; concurrent use of trastuzumab is not permitted; concurrent use of zoledronic acid is allowed
- serum albumin less than 3.0 g/dL within the last 30 days
- creatinine clearance (CrCL) or glomerular filtration rate (GFR) less than 60 mL/min [/body surface area (BSA)] (within the last 30 days)
- inability to understand and give informed consent to participate
- patients with a history of inflammatory bowel disease requiring therapy or patients with chronic diarrhea syndromes or paralytic ileus
- patients with prior or concurrent pelvic irradiation
- patients who use an ostomy for fecal excretion
- there is no limit on the number of prior chemotherapies; the decision to use capecitabine is determined solely by the treating physician
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977119
Contacts
| Contact: Peter H O'Donnell, MD | (773) 702-4400 | podonnel@medicine.bsd.uchicago.edu |
Locations
| United States, Alabama | |
| University of Alabama - Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: Carla I Falkson, MD | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Principal Investigator: Minetta Liu, MD | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Peter H O'Donnell, MD 773-702-4400 podonnel@medicine.bsd.uchicago.edu | |
| Principal Investigator: Peter H O'Donnell, MD | |
| NorthShore University HealthSystem | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Principal Investigator: Douglas Merkel, MD | |
| United States, Indiana | |
| Indiana University Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: Anna Maria Storniolo, MD | |
| United States, Maryland | |
| Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: Antonio Wolff, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: Cathy van Poznak, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Mayo Clinic, Clinical Trials Office 507-538-7623 | |
| Principal Investigator: James Ingle, MD | |
| United States, North Carolina | |
| University of North Carolina - Chapel Hill | Not yet recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: William Irvin Jr., MD | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27708 | |
| Principal Investigator: Jeffrey Peppercorn, MD | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | Recruiting |
| Nashville, Tennessee, United States, 73232 | |
| Principal Investigator: Ingrid Mayer, MD | |
| United States, Texas | |
| M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Amal Melham-Bertrandt, MD | |
| Baylor University | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Mothaffar F Rimawi, MD | |
Sponsors and Collaborators
University of Chicago
Translational Breast Cancer Reserach Consortium
Investigators
| Study Chair: | Peter H O'Donnell, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Peter O' Donnell, Instructor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00977119 History of Changes |
| Other Study ID Numbers: | 09-056-B, TBCRC 015 |
| Study First Received: | September 14, 2009 |
| Last Updated: | August 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
breast cancer capecitabine |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Capecitabine Fluorouracil Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013