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A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients


N/A
18 Years
N/A
Not Enrolling
Both
Anemia, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Pilot Trial of Extended Interval Dosing of Epoetin Alfa (Procrit®) for the Treatment of Anemia in Oncology Patients


OBJECTIVES:

Primary

- Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit
levels, of interval dosing with epoetin alfa in treating patients with anemia
undergoing chemotherapy for nonhematologic cancer.

Secondary

- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

- Correlate hemoglobin and hematocrit response with patient age (> 65 years vs < 65
years) in patients treated with this drug.

- Determine quality of life of patients treated with this drug.

- Determine the adverse effects of this drug in these patients.

- Determine the change over time of symptom and quality of life variables (e.g., fatigue)
in patients treated with this drug.

OUTLINE: This is a partially randomized, pilot study. Patients are stratified according to
age (< 65 years vs ≥ 65 years). Patients are assigned to 1 of 2 treatment groups based on
participation in the pharmacokinetic (PK) portion of the study.

- Group 1 (PK study, initial therapy): Patients are randomized to 1 of 2 treatment arms.

- Arm I: Five patients receive epoetin alfa subcutaneously (SC) once weekly.
Treatment continues for 24 weeks in the absence of unacceptable toxicity.

- Arm II: Five 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 in both arms also undergo PK sampling periodically during study treatment.

- Group 2 (non-PK study, initial therapy): Fifteen 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.

- Maintenance therapy: Patients receive epoetin alfa SC once every other week for up to
24 weeks of total treatment (including both initial therapy and maintenance therapy).
Patients whose blood counts fall below the critical levels are placed on a weekly
dosing schedule. Patients whose blood counts rise too high discontinue study drug until
blood counts are reduced.

Quality of life (including fatigue) is assessed at baseline and then every 4 weeks for 28
weeks.

After completion of study therapy, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Inclusion Criteria


ELIGIBILITY CRITERIA

- 18 years of age or greater

- Must have Hb less than 11 g/dl and normal hematopoesis

- Must have non-myeloid malignancies treated with myelosuppressive therapy *Must
have an ECOG performance status of 0-2

- Must have a life expectancy of 6 months or greater

- Must have adequate liver function (bilirubin less than or equal to 2.0 mg) and renal
function (creatinine less than or equal to 2.0 mg)

- Must have normal serum folate and vitamin B12 levels or be receiving replacement
therapy

- Must be iron replete (transferring saturation great than or equal to 20 percent and
ferritin greater than or equal to 100 mg/ml) or be receiving replacement therapy

- Must be able to fully comprehend and give written consent.

- Female patients with reproductive potential must be practicing an effective method of
birth control (e.g., abstinence, prescription oral contraceptives, contraceptive
injections, intrauterine device, double-barrier method, contraceptive patch, surgical
sterilization) before entry and throughout the study.

- Female patients with reproductive potential must have a negative serum HCG
pregnancy test at screening (within 7 days before the first dose of study drug)

Exclusion criteria

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Joseph Bubalo, PharmD, BCPS, BCOP

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000445450

NCT ID:

NCT00258440

Start Date:

May 2003

Completion Date:

September 2008

Related Keywords:

  • Anemia
  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • fatigue
  • anemia
  • unspecified adult solid tumor, protocol specific
  • Anemia
  • Fatigue

Name

Location

OHSU Knight Cancer Institute Portland, Oregon  97239