Clinical trial NCT00258440
Conditions: Anemia Fatigue Unspecified Adult Solid Tumor, Protocol Specific
Keywords: fatigue anemia unspecified adult solid tumor, protocol specific
Sponsor: OHSU Knight Cancer Institute
Start date: 2003-05-01; Completion date: 2008-09-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:
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.

Arms: arm 1: Weekly dosing schedule subjects will get the study drug once every week until the end of the study. arm 2: 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 arm 3: 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.
Interventions: intervention 1: Weekly procrit dosing intervention 2: Interval Dosing
Intervention descriptions: intervention 1: 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. intervention 2: The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.

Protocol documents: