Breast CancerNCT01542203
Impact of Body Weight on Pharmacokinetic Analysis of Doxorubicin + Cyclophosphamide in Breast Cancer
An observational study of Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This study is designed to measure drug concentrations in the blood of 18 female breast cancer patients who require doxorubicin (30 minute infusion) and cyclophosphamide (30 minute infusion) as part of standard medical care. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2012to 5 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Females,
- age 18 years of age or older, of all racial and ethnic origins that are scheduled to receive the first cycle of a single intravenous dose of doxorubicin (30 minute infusion) and cyclophosphamide (30 minute infusion) as part of standard medical care for breast cancer.
- English and/or Spanish speaking participants are eligible to participate.
Who cannot join
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of doxorubicin and cyclophosphamide on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of doxorubicin or cyclophosphamide, so that the pregnancy and post-partum state would be a confounding variable.
- Participants unwilling to comply with study procedures.
- CrCl < 10 ml/min
- Participants requiring peritoneal or hemodialysis
- Serum bilirubin > 1.19 mg/dL
- Receipt of the following drugs that:
Show all 9Show fewer
- Alter doxorubicin concentrations: carbamazepine, cyclosporine, fosphenytoin, paclitaxel, phenytoin, sorafenib, valspodar, verapamil
- Alter cyclophosphamide concentrations: cyclosporine, nevirapine, ondansetron
- All other drugs will be reviewed during screening of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Body Weight on the Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide in Breast Cancer Patients
This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This study is designed to measure drug concentrations in the blood of 18 female breast cancer patients who require doxorubicin (30 minute infusion) and cyclophosphamide (30 minute infusion) as part of standard medical care. Up to a total of 40 adult female participants will be consented for the study at the cancer center. Eighteen of these participants are needed to complete the study. The others will likely be screen failures. The participants will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just prior to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h after the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The intravenous catheter will be removed when the participant is discharged from the cancer center on day 1. The participant will be asked to return to the cancer center at 12-24 and 24-72 hours to have the final 2 blood draws conducted. The participants must be treated with Doxorubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis study.
Read the detailed description
The study will require a total of 11 participant contacts over 3 days (1 day outpatient clinic visit for doxorubicin and cyclophosphamide infusions and blood draws, 2 follow up outpatient clinic visits for blood draws) with no more than 100 mL of blood being drawn. All blood draws will be collected for the purpose of research.
Screening and Informed Consent Procedures
- The participant's height, weight, medical history, comorbid conditions, and current medications will be obtained from the electronic medical record (EMR). Update 1 : January 12, 2012
- Study personnel will provide the participant with additional information about the study and provide the participant with the opportunity to ask any questions. Each participant will then be asked if she is willing to provide informed consent.
- Information from the routine physical examination including vital signs (temperature,respiratory rate, blood pressure, heart rate) will be collected from the medical chart.
Procedures and Evaluation during the Research
- Each participant will then have no more than10ml of blood drawn 8 times, at t=0h (predose),at the end of the doxorubicin infusion, at the end cyclophosphamide infusion, and 1.5, 2, 3, 4, 5, 12-24, and 24-72 h following the beginning of doxorubicin infusion. All blood draws will be performed using the peripheral intravenous catheter being used for standard medical care. Labels on blood samples will not contain participant name, but a randomly generated participant identification number.
- All blood samples will placed on ice and immediately transported to Dr. Richard Leff's laboratory for sample preparation.9 Samples will be spun in a refrigerated centrifuge and then placed in a -80oC freezer. As explained below, Dr. Leff or his laboratory will not have access to any participant identifiers.
- The participant is discharged from the cancer center (for research purposes) after the 4 hour blood draw, unless the participant is willing to stay for the 5 hour blood draw.
- The participant will return to the cancer center at 12-24 and 24-72 hours for blood draws.
- The participant is discharged from the study after the 24-72h blood draw. Follow-up: Participants will be asked to return to the cancer center for 12-24 and 24-72 hour blood draws.
- Conditions
- Breast Cancer
- Keywords
- doxorubicin, cyclophosphamide, Breast Cancer, BMI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer, Various BMIs | 18 female breast cancer patients who are normal weight (body mass index [BMI] < 25 kg/m2, overweight or class I obese(BMI 25-34.9 kg/m2), or class II-III obese (BMI > 35 kg/m2). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study start25 Jun 2012
- Primary completion15 Sep 2016
- Study completion5 Jun 2017
Why it stopped: study is classified as ancillary / correlative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542203
- Sponsor's protocol ID
- STU 062011-056
- Status last verified
- Jun 2018
- First submitted
- 20 Feb 2012
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Body Weight on the Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01542203
- Acronym / sponsor ID
- STU 062011-056
- Conditions
- Breast Cancer
- Keywords
- doxorubicin, cyclophosphamide, Breast Cancer, BMI
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study is classified as ancillary / correlative
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Texas Tech University Health Sciences Center
- Study start
- 25 Jun 2012 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single site study will be conducted at the UT Southwestern Simmons Cancer Center. This study is designed to measure drug concentrations in the blood of 18 female breast cancer patients who require doxorubicin (30 minute infusion) and cyclophosphamide (30 minute infusion) as part of standard medical care. Up to a total of 40 adult female participants will be consented for the study at the cancer center. Eighteen of these participants are needed to complete the study. The others will likely be screen failures. The participants will have no more than 100 ml of blood drawn via a peripheral intravenous catheter just prior to the doxorubicin infusion, and then at 0.5, 1, 1.5, 2, 3, 4, 5, 12-24, and 24-72 h after the beginning of the doxorubicin infusion. The 5 hour blood draw is optional. The intravenous catheter will be removed when the participant is discharged from the cancer center on day 1. The participant will be asked to return to the cancer center at 12-24 and 24-72 hours to have the final 2 blood draws conducted. The participants must be treated with Doxorubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis study.
Detailed description
The study will require a total of 11 participant contacts over 3 days (1 day outpatient clinic visit for doxorubicin and cyclophosphamide infusions and blood draws, 2 follow up outpatient clinic visits for blood draws) with no more than 100 mL of blood being drawn. All blood draws will be collected for the purpose of research.
Screening and Informed Consent Procedures
- The participant's height, weight, medical history, comorbid conditions, and current medications will be obtained from the electronic medical record (EMR). Update 1 : January 12, 2012
- Study personnel will provide the participant with additional information about the study and provide the participant with the opportunity to ask any questions. Each participant will then be asked if she is willing to provide informed consent.
- Information from the routine physical examination including vital signs (temperature,respiratory rate, blood pressure, heart rate) will be collected from the medical chart.
Procedures and Evaluation during the Research
- Each participant will then have no more than10ml of blood drawn 8 times, at t=0h (predose),at the end of the doxorubicin infusion, at the end cyclophosphamide infusion, and 1.5, 2, 3, 4, 5, 12-24, and 24-72 h following the beginning of doxorubicin infusion. All blood draws will be performed using the peripheral intravenous catheter being used for standard medical care. Labels on blood samples will not contain participant name, but a randomly generated participant identification number.
- All blood samples will placed on ice and immediately transported to Dr. Richard Leff's laboratory for sample preparation.9 Samples will be spun in a refrigerated centrifuge and then placed in a -80oC freezer. As explained below, Dr. Leff or his laboratory will not have access to any participant identifiers.
- The participant is discharged from the cancer center (for research purposes) after the 4 hour blood draw, unless the participant is willing to stay for the 5 hour blood draw.
- The participant will return to the cancer center at 12-24 and 24-72 hours for blood draws.
- The participant is discharged from the study after the 24-72h blood draw. Follow-up: Participants will be asked to return to the cancer center for 12-24 and 24-72 hour blood draws.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer, Various BMIs | – | –18 female breast cancer patients who are normal weight (body mass index [BMI] < 25 kg/m2, overweight or class I obese(BMI 25-34.9 kg/m2), or class II-III obese (BMI > 35 kg/m2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- Females,
- age 18 years of age or older, of all racial and ethnic origins that are scheduled to receive the first cycle of a single intravenous dose of doxorubicin (30 minute infusion) and cyclophosphamide (30 minute infusion) as part of standard medical care for breast cancer.
- English and/or Spanish speaking participants are eligible to participate.
Key exclusion criteria (9 listed)
- Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of doxorubicin and cyclophosphamide on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of doxorubicin or cyclophosphamide, so that the pregnancy and post-partum state would be a confounding variable.
- Participants unwilling to comply with study procedures.
- CrCl < 10 ml/min
- Participants requiring peritoneal or hemodialysis
- Serum bilirubin > 1.19 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.