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Trial record 17 of 2159 for:    doxorubicin

Enalapril Maleate and Doxorubicin Hydrochloride in Treating Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00895414
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: doxorubicin hydrochloride
Drug: enalapril maleate
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxorubicin Alone First, Then Doxorubicin With Enalapril Doxorubicin With Enalapril First, Then Doxorubicin Alone
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Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Beginning 1 week before course 2, patients additionally receive oral enalapril maleate once daily until day 8 of course 2.

Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Beginning 1 week before course 1, patients additionally receive oral enalapril maleate once daily until day 8 of course 1.

Period Title: First Intervention (14 Days)
Started 9 10
Completed 8 9
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             0
Physician Decision             0             1
Period Title: Second Intervention (14 Days)
Started 8 9
Completed 8 9
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Patients who were randomized to receive either doxorubicin hydrochloride alone or doxorubicin hydrochloride with enalapril.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  94.7%
>=65 years
1
   5.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
19
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Number of Patients With Doxorubicin Plasma Concentrations Demonstrating a Significant Increase or Decrease When Doxorubicin Was Given With Enalapril as Compared to When Doxorubicin Was Given Without Enalapril.
Hide Description Doxorubicin plasma concentration (DPC) is the primary pharmacokinetic (PK) measure of the exposure. Each patient will have serial PKs performed twice - once with enalapril and once without enalapril. A mean increase or decrease of more than 115 ng/ml in DPC will be considered significant.
Time Frame Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxorubicin Hydrochloride Alone Doxorubicin Hydrochloride With Enalapril
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Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.
Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.
Overall Number of Participants Analyzed 17 17
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title The Number of Participants With a Significant Increase or Decrease in the Baseline Levels of Btype Natriuretic Peptide, Cardiac Troponins, and Urine Microalbumin With or Without Enalapril
Hide Description Doxorubicin can induce changes in troponin, b-type natriuretic peptide and urine microalbumin. This analysis will determine whether enalapril prevents any of these changes. Statistical significance defined as a p < 0.05.
Time Frame Baseline, 4, 24 and 48 hours after infusion of doxorubicin
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxorubicin Hydrochloride Alone Doxorubicin Hydrochloride With Enalapril
Hide Arm/Group Description:
Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.
Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title The Number of Participants With a Significant Increase or Decrease in Doxorubicin Hydrochloride Metabolite Levels With or Without Enalapril
Hide Description Doxorubicin is metabolized to doxorubicinol. The effects of enalapril on doxorubicinol will be assessed. Statistical significance defined as a p < 0.05.
Time Frame Baseline, 0.5, 1.0, 2.0, 4.0, 24.0 and 48.0 hours after infusion of doxorubicin
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Doxorubicin Hydrochloride Alone Doxorubicin Hydrochloride With Enalapril
Hide Arm/Group Description:
Participants who received doxorubicin hydrochloride alone in either Cycle 1 or Cycle 2.
Participants who received doxorubicin hydrochloride with enalapril in either Cycle 1 or Cycle 2.
Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description The adverse events could not be reported per intervention because the arms themselves were designed originally as one being "Doxorubicin Alone First, Then Doxorubicin With Enalapril" and the other being "Doxorubicin With Enalapril First, Then Doxorubicin Alone." As such the data was collected and reported under these two arms and it would not be possible further separate the adverse events by "Doxorubicin Hydrochloride Alone" and "Doxorubicin Hydrochloride With Enalapril."
 
Arm/Group Title Doxorubicin Alone First, Then Doxorubicin With Enalapril Doxorubicin With Enalapril First, Then Doxorubicin Alone
Hide Arm/Group Description

Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Beginning 1 week before course 2, patients additionally receive oral enalapril maleate once daily until day 8 of course 2.

Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Beginning 1 week before course 1, patients additionally receive oral enalapril maleate once daily until day 8 of course 1.

All-Cause Mortality
Doxorubicin Alone First, Then Doxorubicin With Enalapril Doxorubicin With Enalapril First, Then Doxorubicin Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Doxorubicin Alone First, Then Doxorubicin With Enalapril Doxorubicin With Enalapril First, Then Doxorubicin Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxorubicin Alone First, Then Doxorubicin With Enalapril Doxorubicin With Enalapril First, Then Doxorubicin Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   3/8 (37.50%)   2/9 (22.22%) 
Cardiac disorders     
palpitations  1/8 (12.50%)  0/9 (0.00%) 
Gastrointestinal disorders     
chest pain, NOS  1/8 (12.50%)  0/9 (0.00%) 
food poisoning  1/8 (12.50%)  0/9 (0.00%) 
General disorders     
fatigue  1/8 (12.50%)  0/9 (0.00%) 
Nervous system disorders     
tingling  0/8 (0.00%)  1/9 (11.11%) 
lightheaded  0/8 (0.00%)  1/9 (11.11%) 
dizziness  3/8 (37.50%)  0/9 (0.00%) 
headache  0/8 (0.00%)  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders     
cough  1/8 (12.50%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders     
rash  0/8 (0.00%)  1/9 (11.11%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anne Blaes
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-8138
EMail: blaes004@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00895414     History of Changes
Other Study ID Numbers: 2008NTLS060
0806M34981 ( Other Identifier: IRB, University of Minnesota )
First Submitted: May 7, 2009
First Posted: May 8, 2009
Results First Submitted: August 25, 2017
Results First Posted: May 8, 2019
Last Update Posted: May 8, 2019