Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
1 other identifier
interventional
224
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2003
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 10, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedResults Posted
Study results publicly available
September 23, 2009
CompletedFebruary 20, 2018
January 1, 2018
2.7 years
October 10, 2005
June 24, 2009
January 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
During Stage 2 (week 9 through week 21)
Study Arms (4)
Venofer + erythropoietin (responders)
ACTIVE COMPARATORerythropoietin only (responders)
ACTIVE COMPARATORVenofer+erythropoietin(non-responders)
ACTIVE COMPARATORerythropoietin only (non-responders)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Histological Diagnosis of Cancer
- Hgb \</= 10
- Ongoing or Planned Chemotherapy
- Body Weight \>50kg
- Free of Active Infection
- Karnofsky Status 60% to 100%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark A. Falone, MD
- Organization
- Luitpold Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2005
First Posted
October 12, 2005
Study Start
February 1, 2003
Primary Completion
October 1, 2005
Study Completion
December 1, 2005
Last Updated
February 20, 2018
Results First Posted
September 23, 2009
Record last verified: 2018-01