Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00416624
First received: December 27, 2006
Last updated: December 19, 2016
Last verified: September 2015
Results First Received: September 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Anemia
Leukemia
Lymphoma
Lymphoproliferative Disorder
Multiple Myeloma and Plasma Cell Neoplasm
Precancerous Condition
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: darbepoetin alfa
Drug: epoetin alfa
Procedure: fatigue assessment and management
Procedure: quality-of-life assessment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Two hundred and thirty-nine (239) participants were enrolled at 10 Mayo Clinic Cancer Research Consortium (MCCRC) sites between February 2007 and December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were two canceled participants and 1 ineligible participants prior to study medication begins. These three participants were excluded from all analysis.

Reporting Groups
  Description
Epoetin Alfa - 40k Weekly Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
Epoetin Alfa - 80k Every 3 Weeks Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
Epoetin Alfa - 120k Every 3 Weeks Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
Darbepoetin Alfa - 500 mcg Every 3 Weeks Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)

Participant Flow:   Overall Study
    Epoetin Alfa - 40k Weekly   Epoetin Alfa - 80k Every 3 Weeks   Epoetin Alfa - 120k Every 3 Weeks   Darbepoetin Alfa - 500 mcg Every 3 Weeks
STARTED   61   60   58   57 
COMPLETED   39   33   40   40 
NOT COMPLETED   22   27   18   17 
Withdrawal by Subject                1                6                4                9 
Death                4                7                7                1 
Adverse Event                8                3                2                2 
Not Specified                8                11                5                5 
Cancel                1                0                0                0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients that were evaluable per protocol.

Reporting Groups
  Description
Epoetin Alfa - 40k Weekly Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
Epoetin Alfa - 80k Every 3 Weeks Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
Epoetin Alfa - 120k Every 3 Weeks Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
Darbepoetin Alfa - 500 mcg Every 3 Weeks Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
Total Total of all reporting groups

Baseline Measures
   Epoetin Alfa - 40k Weekly   Epoetin Alfa - 80k Every 3 Weeks   Epoetin Alfa - 120k Every 3 Weeks   Darbepoetin Alfa - 500 mcg Every 3 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   60   58   57   236 
Age 
[Units: Years]
Median (Full Range)
 65.0 
 (44.0 to 94.0) 
 68.0 
 (37.0 to 91.0) 
 65.0 
 (19.0 to 81.0) 
 67.0 
 (40.0 to 89.0) 
 66.0 
 (19.0 to 94.0) 
Gender 
[Units: Participants]
Count of Participants
         
Female      37  60.7%      24  40.0%      33  56.9%      42  73.7%      136  57.6% 
Male      24  39.3%      36  60.0%      25  43.1%      15  26.3%      100  42.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      1   1.7%      0   0.0%      1   0.4% 
Asian      0   0.0%      1   1.7%      1   1.7%      0   0.0%      2   0.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3   4.9%      2   3.3%      4   6.9%      5   8.8%      14   5.9% 
White      58  95.1%      57  95.0%      52  89.7%      52  91.2%      219  92.8% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   61   60   58   57   236 
Anemia 
[Units: Participants]
         
Mild: Hemoglobin of 9.5-11   45   43   43   42   173 
Severe: Hemoglobin < 9.5   16   17   15   15   63 
Platinum Containing Regimen 
[Units: Participants]
         
Yes   27   27   27   25   106 
No   34   33   31   32   130 
Primary Tumor Type 
[Units: Participants]
         
Hematologic   5   6   5   4   20 
Solid Tumor   56   54   53   53   216 
Height 
[Units: Cm]
Median (Full Range)
 167.6 
 (149.7 to 193.0) 
 168.0 
 (154.0 to 201.0) 
 165.2 
 (150.0 to 190.0) 
 166.5 
 (152.4 to 187.0) 
 167.0 
 (149.7 to 201.0) 
Baseline Hemoglobin 
[Units: g/dL]
Median (Full Range)
 10.1 
 (7.8 to 10.6) 
 9.9 
 (8.4 to 10.5) 
 9.9 
 (7.7 to 10.5) 
 9.9 
 (7.4 to 10.5) 
 9.9 
 (7.4 to 10.6) 
Weight 
[Units: Kg]
Median (Full Range)
 69.1 
 (44.5 to 125.4) 
 72.6 
 (51.3 to 133.0) 
 70.6 
 (44.1 to 120.0) 
 71.0 
 (42.5 to 141.0) 
 71.3 
 (42.5 to 141.0) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants Who Exhibit a Hematopoietic Response   [ Time Frame: 20 weeks ]

2.  Secondary:   Weekly Change in Hemoglobin Levels   [ Time Frame: Baseline and Week 4, 7, 10, 13, 16 ]

3.  Secondary:   Time Required to Achieve Hemoglobin Levels >= 11.5 g/dL   [ Time Frame: 16 weeks ]

4.  Secondary:   Mean Hemoglobin Change From Week 1 to Week 16   [ Time Frame: Week 1 and Week 16 ]

5.  Secondary:   The Percentage of Participants Requiring Red Blood Cell (RBC) Transfusions   [ Time Frame: 16 weeks ]

6.  Secondary:   The Total RBC Transfusion Needed   [ Time Frame: 16 weeks ]

7.  Secondary:   The Percentage of Participants With Dose Omitted Due to Hematologic Reason   [ Time Frame: 16 Weeks ]

8.  Secondary:   The Percentage of Participants Reported Grade 3 or 4 Adverse Events   [ Time Frame: 16 weeks ]

9.  Secondary:   Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations   [ Time Frame: Weeks 4, 7, 10, 13 and 16 ]

10.  Secondary:   Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation   [ Time Frame: Weeks 4, 7, 10, 13 and 16 ]

11.  Secondary:   Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations   [ Time Frame: Weeks 4, 7, 10, 13 and 16 ]

12.  Secondary:   Quality of Life as Measured by Symptom Distress Scale (SDS) Over All Follow-up Evaluations   [ Time Frame: Weeks 4, 7, 10, 13 and 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Charles L. Loprinzi, M.D.
Organization: Mayo Clinic
phone: 507-266-6247
e-mail: loprinzi.charles@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00416624     History of Changes
Other Study ID Numbers: CDR0000522677
P30CA015083 ( US NIH Grant/Contract Award Number )
RC05CB ( Other Identifier: Mayo Clinic Cancer Center & MCCRC )
06-002991 ( Other Identifier: Mayo Clinic IRB )
EPOANE3015 ( Other Identifier: Centocor protocol )
Study First Received: December 27, 2006
Results First Received: September 10, 2015
Last Updated: December 19, 2016