Anemia
Conditions
Keywords
Anemia, Cancer, Chemotherapy
Brief summary
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
Detailed description
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.
Interventions
DRUGiron sucrose injection USP
DRUGstable erythropoietin therapy
Sponsors
American Regent, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological Diagnosis of Cancer * Hgb \</= 10 * Ongoing or Planned Chemotherapy * Body Weight \>50kg * Free of Active Infection * Karnofsky Status 60% to 100%
Exclusion criteria
* Active infection * Use of Multivitamins with iron within one week of entry * Myelophthisic bone marrow involvement by tumor except hematologic malignancy * Concurrent medical condition that would prevent compliance or jeopardize the health of the patient * Use of any IV iron products within two months of study entry * Blood Transfusions * Hypoplastic bone marrow failure state * Acute Leukemia * Myeloproliferative syndrome * Uncontrolled hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). | During Stage 2 (week 9 through week 21) | The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8). |
Participant flow
Recruitment details
July 18, 2003 - October 27, 2005 Locations: Hospitals and Medical Clinics (33 total sites)
Pre-assignment details
Anemia defined as a hemoglobin level \< or = to 10.0 g/dL.
Participants by arm
| Arm | Count |
|---|---|
| Group A: Erythropoietin + Venofer (Responders) Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. | 59 |
| Group B: Erythropoietin Only (Responders) Subjects who at any time during Stage 1 (8-week duration) showed a \> or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only. | 77 |
| Group C: Erythropoietin + Venofer (Non-responders) Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. | 40 |
| Group D: Erythropoietin Only (Non-responders) Subjects whose maximum hemoglobin increase was \< 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only. | 48 |
| Total | 224 |
Baseline characteristics
| Characteristic | Group A: Erythropoietin + Venofer (Responders) | Group B: Erythropoietin Only (Responders) | Group C: Erythropoietin + Venofer (Non-responders) | Group D: Erythropoietin Only (Non-responders) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 35 Participants | 17 Participants | 23 Participants | 100 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 42 Participants | 23 Participants | 25 Participants | 124 Participants |
| Sex: Female, Male Female | 39 Participants | 49 Participants | 28 Participants | 31 Participants | 147 Participants |
| Sex: Female, Male Male | 20 Participants | 28 Participants | 12 Participants | 17 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 50 / 59 | 48 / 77 | 32 / 40 | 35 / 48 |
| serious Total, serious adverse events | 13 / 59 | 14 / 77 | 11 / 40 | 11 / 48 |
Outcome results
Primary
Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).
The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).
Time frame: During Stage 2 (week 9 through week 21)
Population: intention to treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: Erythropoietin + Venofer (Responders) | Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). | 2.6 g/dL | Standard Deviation 1.59 |
| Group B: Erythropoietin Only (Responders) | Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). | 1.8 g/dL | Standard Deviation 1.39 |
| Group C: Erythropoietin + Venofer (Non-responders) | Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). | 2.5 g/dL | Standard Deviation 1.88 |
| Group D: Erythropoietin Only (Non-responders) | Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). | 1.3 g/dL | Standard Deviation 1.73 |