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

NCT00258440 | Terminated Results DMC

• 5 other identifiers: CDR0000445450OHSU-ONC-03017-LPOHSU-1616OHSU-7754ORTHO-ONC-03017-LP
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with anemia. PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.

Conditions

Anemia; Fatigue; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

fatigue; anemia; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks

  12 weeks

Secondary Outcomes (3)

• Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.

  every other week

• Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28

  weeks 4,8,16,24 and 28

• Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.

  On study, averaging 3 to 6 months.

Study Arms (3)

Weekly Procrit (epoetin alfa) dosing

ACTIVE COMPARATOR

Weekly dosing schedule subjects will get the study drug once every week until the end of the study.

Drug: Weekly procrit dosing

Interval Dosing (epoetin alfa) PK Group

EXPERIMENTAL

Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who consented to pharmacokinetic testing

Drug: Interval Dosing

Interval Dosing (epoetin alfa) Non PK Group

EXPERIMENTAL

Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who did not consent to pharmacokinetic testing.

Drug: Interval Dosing

Interventions

Weekly procrit dosing DRUG

The dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week.

Weekly Procrit (epoetin alfa) dosing

Interval Dosing DRUG

The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.

Interval Dosing (epoetin alfa) Non PK Group; Interval Dosing (epoetin alfa) PK Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patient has uncontrolled hypertension
• Patient has history of symptomatic cardiac disease
• Patient has serious intercurrent illness
• The patient is pregnant, has a positive serum HCG or is lactating Patient has known hypersensitivity to mammalian cell-derived products or human albumin.
• Patient has diagnosis of polycythemia vera, chronic myelogenous leukemia, myelodysplastic syndrome
• May not be due for transplant within 24 weeks
• Anemia due to factors other than cancer.
• History of a thrombotic vascular event.
• History of seizures
• Patient has received a red blood cell growth factor (epoetin alfa or darbepoetin) within the last 60 days

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Anemia; Fatigue

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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

Results Point of Contact

• Title: Joseph Bubalo
• Organization: Oregon Health and Science Univeristy

bubaloj@ohsu.edu

503-494-8007

Study Officials

• Joseph Bubalo, PharmD, BCPS, BCOP

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: November 23, 2005
• First Posted: November 24, 2005
• Study Start: May 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 9, 2017
• Results First Posted: May 26, 2011

Record last verified: 2017-05

Locations

US (1)