Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia (Procrit)
Primary Purpose
Anemia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epoetin Alfa plus Iron
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring advanced lung cancer, Procrit, Epoetin Alfa, Ferric Gluconate, iron supplementation
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed small cell or non small cell lung cancer
- Stage III or Stage IV lung cancer
- Platinum containing chemotherapy induced anemia (< 10 g/dl Hb)
- Cancer related anemia (<10 g/dl Hb) at time of initiation of chemotherapy
- ECOG performance status of 0,1, or 2
- Informed consent
- Age>18
- Expected to receive platinum based outpatient chemotherapy for at least nine weeks
Exclusion Criteria:
- Pregnant women
- Intolerance to epoetin alfa or parenteral iron
- More than 2 cycles of the planned platinum chemotherapy at time of enrollment
- Chronic GI bleed (> than 4 weeks positive hemoccult or gastroccult)
- Ferritin > 500 mg/dl
- Anemia due to other causes than cancer or chemotherapy
- Previous parenteral iron therapy
- Uncontrolled hypertension (systolic BP > 160, diastolic > 100 mmHg)
Sites / Locations
- James Graham Brown Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epoetin Alfa plus Iron
Arm Description
Outcomes
Primary Outcome Measures
Achieve hemoglobin responses > 2g/dl in at least 70% of patients
Secondary Outcome Measures
Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks
Full Information
NCT ID
NCT00481624
First Posted
June 1, 2007
Last Updated
March 1, 2018
Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00481624
Brief Title
Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia
Acronym
Procrit
Official Title
A Phase II Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study was stopped because of lack of funding.
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find a better, more convenient way to improve anemia results by increasing the amount of medication given at 3 week intervals. Researchers want to know if giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give better results in treating anemia without the need for more office visits.
Detailed Description
There are more than 170,000 patients diagnosed with lung cancer in the United States each year and many will develop anemia (iron deficiency) during the course of treatment. Anemia is associated with poor quality of life and treatment delays for advanced lung cancer. The treatment of iron deficiency anemia is with iron. Iron is an essential mineral used in red blood cells to carry oxygen throughout the body. Iron is necessary to make hemoglobin, a key element in red blood cells.
The FDA has approved Procrit® (epoetin alfa) to treat anemia in people with non-myeloid (bone marrow) malignancies. Procrit® is a man-made, injectable drug for treating anemia and it encourages red cell production. While the administration of intravenous iron therapy, injected into veins through an IV, did increase the response rate of Procrit® in a previous study, researchers want to find out the best amount of drug to use and the best time to administer Procrit®, along with ferric gluconate, (Ferrlecit®), added for lack of iron.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
advanced lung cancer, Procrit, Epoetin Alfa, Ferric Gluconate, iron supplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epoetin Alfa plus Iron
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa plus Iron
Other Intervention Name(s)
Procrit®; Ferrlecit®
Intervention Description
One (1) injection of Procrit®, by needle, inserted just under the skin;
125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein.
These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.
In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan.
Primary Outcome Measure Information:
Title
Achieve hemoglobin responses > 2g/dl in at least 70% of patients
Time Frame
Nine weeks, after at least two doses of 120,000 units epoetin alfa
Secondary Outcome Measure Information:
Title
Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks
Time Frame
Patient follow up until week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed small cell or non small cell lung cancer
Stage III or Stage IV lung cancer
Platinum containing chemotherapy induced anemia (< 10 g/dl Hb)
Cancer related anemia (<10 g/dl Hb) at time of initiation of chemotherapy
ECOG performance status of 0,1, or 2
Informed consent
Age>18
Expected to receive platinum based outpatient chemotherapy for at least nine weeks
Exclusion Criteria:
Pregnant women
Intolerance to epoetin alfa or parenteral iron
More than 2 cycles of the planned platinum chemotherapy at time of enrollment
Chronic GI bleed (> than 4 weeks positive hemoccult or gastroccult)
Ferritin > 500 mg/dl
Anemia due to other causes than cancer or chemotherapy
Previous parenteral iron therapy
Uncontrolled hypertension (systolic BP > 160, diastolic > 100 mmHg)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goetz H Kloecker, MD
Organizational Affiliation
James Graham Brown Cancer Center, Univeristy of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.browncancercenter.org
Description
James Graham Brown Cancer Center, Louisville, KY
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Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia
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