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Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

This study has been terminated.
(Sponsor discontinued funding of the study)
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00258440
First received: November 23, 2005
Last updated: June 1, 2011
Last verified: June 2011
Results First Received: June 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Anemia
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: Weekly procrit dosing
Drug: Interval Dosing

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were adults age >=18yrs, with solid tumors, and who received treatment. A total of 25 subjects were recruited. Potential study subjects were seen in a routine clinical setting or referred for study purposes. The PI, physician or the research nurse approached subject and to get informed consent, as well as screen for eligibility.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Weekly Procrit (Epoetin Alfa) Dosing Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
Interval Dosing (Epoetin Alfa) PK Group Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
Interval Dosing (Epoetin Alfa) Non PK Group Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.

Participant Flow:   Overall Study
    Weekly Procrit (Epoetin Alfa) Dosing     Interval Dosing (Epoetin Alfa) PK Group     Interval Dosing (Epoetin Alfa) Non PK Group  
STARTED     1     0     6  
COMPLETED     1     0     5  
NOT COMPLETED     0     0     1  
Withdrawal by Subject                 0                 0                 1  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Weekly Procrit (Epoetin Alfa) Dosing Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
Interval Dosing (Epoetin Alfa) PK Group Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
Interval Dosing (Epoetin Alfa) Non PK Group Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
Total Total of all reporting groups

Baseline Measures
    Weekly Procrit (Epoetin Alfa) Dosing     Interval Dosing (Epoetin Alfa) PK Group     Interval Dosing (Epoetin Alfa) Non PK Group     Total  
Number of Participants  
[units: participants]
  1     0     6     7  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     1     0     6     7  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     0     0     5     5  
Male     1     0     1     2  
Region of Enrollment  
[units: participants]
       
United States     1     0     6     7  



  Outcome Measures
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1.  Primary:   Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks   [ Time Frame: 12 weeks ]

2.  Secondary:   Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.   [ Time Frame: On study, averaging 3 to 6 months. ]

3.  Secondary:   Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.   [ Time Frame: every other week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28   [ Time Frame: weeks 4,8,16,24 and 28 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Due to low accruals the sponsor decided to discontinue the study early. A full analysis was not completed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joseph Bubalo
Organization: Oregon Health and Science Univeristy
phone: 503-494-8007
e-mail: bubaloj@ohsu.edu


No publications provided


Responsible Party: Joseph Bubalo, PharmD, BCPS, BCOP, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00258440     History of Changes
Other Study ID Numbers: CDR0000445450, OHSU-ONC-03017-LP, OHSU-1616, OHSU-7754, ORTHO-ONC-03017-LP
Study First Received: November 23, 2005
Results First Received: June 10, 2010
Last Updated: June 1, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration