An interventional study of Weekly procrit dosing and Interval Dosing in Anemia, Fatigue and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by OHSU Knight Cancer Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by OHSU Knight Cancer Institute · Not applicable, Interventional, and Supportive care
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.
OBJECTIVES:
Primary
Secondary
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.
Patients in both arms also undergo PK sampling periodically during study treatment.
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.
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 7 is below the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
ELIGIBILITY CRITERIA
Exclusion criteria
Weekly dosing schedule subjects will get the study drug once every week until the end of the study.
Drug: Weekly procrit dosing
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 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
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.
The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.
Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks
Time frame: 12 weeks
Pharmacokinetics (PK) and Pharmacodynamics Assays That Measure Concentration of Erythropoietin in Serum.
Time frame: every other week
Quality of Life at Baseline and Weeks 4, 8, 16, 24, and 28
Time frame: weeks 4,8,16,24 and 28
Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.
Time frame: On study, averaging 3 to 6 months.
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.
| Milestone | 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 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| participants | Weekly Procrit (Epoetin Alfa) Dosing | Interval Dosing (Epoetin Alfa) PK Group | Interval Dosing (Epoetin Alfa) Non PK Group |
|---|---|---|---|
| Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks | 0 (1 to 6) | — | 5 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
| events | Weekly Procrit (Epoetin Alfa) Dosing | Interval Dosing (Epoetin Alfa) PK Group | Interval Dosing (Epoetin Alfa) Non PK Group |
|---|---|---|---|
| Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability. | 38 | — | 130 |
Collected over Adverse Events were collected for as long as the patient was on study. in some cases that was up to 6 months or as little as 3 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Weekly Procrit (Epoetin Alfa) Dosing | — | 0/1 (0%) | 1/1 (100%) |
| Interval Dosing (Epoetin Alfa) PK Group | — | — | — |
| Interval Dosing (Epoetin Alfa) Non PK Group | — | 1/6 (16.7%) | 6/6 (100%) |
| Event | Weekly Procrit (Epoetin Alfa) Dosing | Interval Dosing (Epoetin Alfa) PK Group | Interval Dosing (Epoetin Alfa) Non PK Group |
|---|---|---|---|
| Failure to thrive, GI bleed, Malignant HypercalcemiaBlood and lymphatic system disorders | 0/1 | — | 1/6 |
| Fever NeutropeniaInfections and infestations | 0/1 | — | 1/6 |
| Event | Weekly Procrit (Epoetin Alfa) Dosing | Interval Dosing (Epoetin Alfa) PK Group | Interval Dosing (Epoetin Alfa) Non PK Group |
|---|---|---|---|
| lymphopeniaBlood and lymphatic system disorders | 1/1 | — | 5/6 |
| PlateletsBlood and lymphatic system disorders | 1/1 | — | 5/6 |
| LeukocytesBlood and lymphatic system disorders | 1/1 | — | 2/6 |
| HyperglycemiaBlood and lymphatic system disorders | 1/1 | — | 5/6 |
| FatigueGeneral disorders | 1/1 | — | 5/6 |
| NauseaGeneral disorders | 1/1 | — | 3/6 |
| HeartburnGastrointestinal disorders | 1/1 | — | 0/6 |
| Mouth painGastrointestinal disorders | 1/1 | — | 0/6 |
| Hemorrhage, noseBlood and lymphatic system disorders | 1/1 | — | 0/6 |
| Hemorrhage, urine traceBlood and lymphatic system disorders | 1/1 | — | 0/6 |
| Age, Categorical(Participants) | Weekly Procrit (Epoetin Alfa) Dosing | Interval Dosing (Epoetin Alfa) PK Group | Interval Dosing (Epoetin Alfa) Non PK Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | — | 0 | 0 |
| Between 18 and 65 years | 1 | — | 6 | 7 |
| >=65 years | 0 | — | 0 | 0 |
| Sex: Female, Male(Participants) | Weekly Procrit (Epoetin Alfa) Dosing | Interval Dosing (Epoetin Alfa) PK Group | Interval Dosing (Epoetin Alfa) Non PK Group | Total |
|---|---|---|---|---|
| Female | 0 | — | 5 | 5 |
| Male | 1 | — | 1 | 2 |
| Region of Enrollment(participants) | Weekly Procrit (Epoetin Alfa) Dosing | Interval Dosing (Epoetin Alfa) PK Group | Interval Dosing (Epoetin Alfa) Non PK Group | Total |
|---|---|---|---|---|
| United States | 1 | — | 6 | 7 |
This study is terminated, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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OHSU Knight Cancer Institute