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

History of Changes

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) Non PK Group
STARTED	1	6
COMPLETED	1	5
NOT COMPLETED	0	1
Withdrawal by Subject	0	1

Baseline Characteristics

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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 ]

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2. Secondary:

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

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3. Secondary:

Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum. [ Time Frame: every other week ]

Results not yet posted. Anticipated Posting 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 posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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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.

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

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