Trial Outcomes & Findings for Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer (NCT NCT00258440)

NCT ID: NCT00258440

Last Updated: 2017-05-09

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-05-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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) 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.
Overall Study STARTED	1	6
Overall Study COMPLETED	1	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weekly Procrit (Epoetin Alfa) Dosing n=1 Participants 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 n=6 Participants 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 n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	6 Participants n=5 Participants	7 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	5 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	6 participants n=5 Participants	7 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Due to low accrual numbers and the discontinuation of the study early a full analysis was not completed.

Outcome measures

Outcome measures
Measure	Weekly Procrit (Epoetin Alfa) Dosing n=1 Participants 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 n=6 Participants 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.
Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks	0 participants Interval 1.0 to 6.0	—	5 participants

SECONDARY outcome

Timeframe: every other week

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: weeks 4,8,16,24 and 28

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: On study, averaging 3 to 6 months.

Outcome measures

Outcome measures
Measure	Weekly Procrit (Epoetin Alfa) Dosing n=1 Participants 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 n=6 Participants 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.
Number of Adverse Events (AEs) Experienced as Measure of Safety and Tolerability.	38 events	—	130 events

Adverse Events

Weekly Procrit (Epoetin Alfa) Dosing

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Interval Dosing (Epoetin Alfa) PK Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Interval Dosing (Epoetin Alfa) Non PK Group

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Weekly Procrit (Epoetin Alfa) Dosing n=1 participants at risk 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 n=6 participants at risk 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.
Blood and lymphatic system disorders Failure to thrive, GI bleed, Malignant Hypercalcemia	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Infections and infestations Fever Neutropenia	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.

Other adverse events

Additional Information

Joseph Bubalo

Oregon Health and Science Univeristy

Phone: 503-494-8007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Weekly Procrit (Epoetin Alfa) Dosing n=1 participants at risk 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 n=6 participants at risk 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.
Gastrointestinal disorders Constipation	0.00% 0/1 • 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.	— 0/0 • 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.	33.3% 2/6 • Number of events 2 • 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.
Gastrointestinal disorders Diarrhea	0.00% 0/1 • 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.	— 0/0 • 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.	33.3% 2/6 • Number of events 2 • 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.
Gastrointestinal disorders Anorexia	0.00% 0/1 • 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.	— 0/0 • 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.	50.0% 3/6 • Number of events 3 • 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.
Blood and lymphatic system disorders lymphopenia	100.0% 1/1 • Number of events 6 • 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.	— 0/0 • 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.	83.3% 5/6 • Number of events 22 • 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.
Blood and lymphatic system disorders Platelets	100.0% 1/1 • Number of events 6 • 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.	— 0/0 • 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.	83.3% 5/6 • Number of events 21 • 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.
Blood and lymphatic system disorders Leukocytes	100.0% 1/1 • Number of events 3 • 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.	— 0/0 • 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.	33.3% 2/6 • Number of events 7 • 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.
Blood and lymphatic system disorders Hyperglycemia	100.0% 1/1 • Number of events 4 • 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.	— 0/0 • 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.	83.3% 5/6 • Number of events 7 • 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.
General disorders Fatigue	100.0% 1/1 • Number of events 2 • 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.	— 0/0 • 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.	83.3% 5/6 • Number of events 8 • 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.
General disorders Nausea	100.0% 1/1 • Number of events 1 • 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.	— 0/0 • 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.	50.0% 3/6 • Number of events 8 • 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.
Gastrointestinal disorders Abdominal bloating	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal cramping	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Dysphagia	0.00% 0/1 • 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.	— 0/0 • 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.	33.3% 2/6 • Number of events 3 • 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.
Gastrointestinal disorders Esophageal pain	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Heartburn	100.0% 1/1 • Number of events 1 • 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.	— 0/0 • 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.	0.00% 0/6 • 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.
Gastrointestinal disorders Mouth pain	100.0% 1/1 • Number of events 1 • 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.	— 0/0 • 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.	0.00% 0/6 • 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.
Gastrointestinal disorders Mucositis	0.00% 0/1 • 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.	— 0/0 • 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.	33.3% 2/6 • Number of events 2 • 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.
Gastrointestinal disorders Increasing abdominal distension	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Gastrointestinal disorders Pain upper abdomen	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 2 • 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.
Gastrointestinal disorders Vomiting	0.00% 0/1 • 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.	— 0/0 • 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.	33.3% 2/6 • Number of events 2 • 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.
Gastrointestinal disorders Abdominal pain/tumor pain	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Blood and lymphatic system disorders Hemorrhage, nose	100.0% 1/1 • Number of events 1 • 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.	— 0/0 • 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.	0.00% 0/6 • 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.
Blood and lymphatic system disorders Hemorrhage, urine trace	100.0% 1/1 • Number of events 1 • 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.	— 0/0 • 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.	0.00% 0/6 • 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.
Infections and infestations Hepatitis	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Infections and infestations Upper respiratory infection	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Blood and lymphatic system disorders Bilateral lower extremity edema	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Blood and lymphatic system disorders Thigh swelling	0.00% 0/1 • 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.	— 0/0 • 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.	16.7% 1/6 • Number of events 1 • 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.
Metabolism and nutrition disorders Abnormal metabolic labs	100.0% 1/1 • Number of events 12 • 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.	— 0/0 • 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.	83.3% 5/6 • Number of events 31 • 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.