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Trial record 46 of 2160 for:    doxorubicin

Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide

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ClinicalTrials.gov Identifier: NCT01537029
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
University of Texas
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Tracking Information
First Submitted Date  ICMJE February 16, 2012
First Posted Date  ICMJE February 22, 2012
Results First Submitted Date  ICMJE July 24, 2018
Results First Posted Date  ICMJE August 22, 2018
Last Update Posted Date August 22, 2018
Actual Study Start Date  ICMJE February 2012
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2018)
Clearance (Cl) for Doxorubicin and Cyclophosphamide [ Time Frame: 0-48 hours ]
Cyclophosphamide analysis was not possible due to rapid drug degradation
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2012)
Area under the curve (AUC) for doxorubicin and cyclophosphamide [ Time Frame: 0-72 hours ]
Change History Complete list of historical versions of study NCT01537029 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Official Title  ICMJE Effect of Weight on the Population Pharmacokinetic Analysis of Doxorubicin and Cyclophosphamide
Brief Summary To determine the effect of weight on doxorubicin and cyclophosphamide plasma clearance in participants 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). The hypothesis is that participants who weigh more will have higher doxorubicin and cyclophosphamide clearances than participants who weigh less. Restated, the area under the drug-concentration time profile, also known as the AUC, in participants will decrease as participant weight increases.
Detailed Description

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 cylcophosphamide (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 Doxurubicin and Cyclophosphamide in order to participate in this pharmacokinetic analysis study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Breast Cancer
  • Obesity
Intervention  ICMJE
  • Drug: Doxorubicin
    Dosed by the patient's treating physician according to local standard of care.
  • Drug: Cyclophosphamide
    dosage form: IV, Dosage, frequency, and duration: According to local standard of care
Study Arms  ICMJE Experimental: Doxorubicin and cyclophosphamide
Interventions:
  • Drug: Doxorubicin
  • Drug: Cyclophosphamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2018)
15
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2012)
18
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 cylcophosphamide (30 minute infusion) as part of standard medical care for breast cancer. English and/or Spanish speaking participants are eligible to participate.

Exclusion Criteria:

  • 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: a) Alter doxorubicin concentrations: carbamazepine, cyclosporine, fosphenytoin, paclitaxel, phenytoin, sorafenib, valspodar, verapamil; b) Alter cyclophosphamide concentrations: cyclosporine, nevirapine, ondansetron; c) All other drugs will be reviewed during screening of the patient
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01537029
Other Study ID Numbers  ICMJE A11-3691
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Texas Tech University Health Sciences Center
Study Sponsor  ICMJE Texas Tech University Health Sciences Center
Collaborators  ICMJE University of Texas
Investigators  ICMJE
Principal Investigator: Ronald G Hall, PharmD Texas Tech University HSC
PRS Account Texas Tech University Health Sciences Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP