AnemiaPhase 2ProcritNCT00481624
Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia
A Phase 2 study testing Epoetin Alfa plus Iron in people with Anemia, run by University of Louisville at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Epoetin Alfa plus Iron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
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
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.
Read the 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.
- Conditions
- Anemia
- Being tested
- Epoetin Alfa plus Iron
- Keywords
- advanced lung cancer, Procrit, Epoetin Alfa, Ferric Gluconate, iron supplementation
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin Alfa plus IronDrug
Also called Procrit®; Ferrlecit®
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin Alfa plus Iron | Experimental | Not described Receives: Drug: Epoetin Alfa plus Iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve hemoglobin responses > 2g/dl in at least 70% of patients
Measured: Nine weeks, after at least two doses of 120,000 units epoetin alfa
Secondary outcomes (1)
Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks
Measured: Patient follow up until week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: The study was stopped because of lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Goetz Kloecker, University of Louisville
- Investigators
- Goetz H Kloecker, MD, Principal investigator, James Graham Brown Cancer Center, Univeristy of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481624
- Sponsor's protocol ID
- 07.0210
- Acronym
- Procrit
- Status last verified
- Mar 2018
- First submitted
- 1 Jun 2007
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00481624
- Acronym / sponsor ID
- Procrit / 07.0210
- Conditions
- Anemia
- Keywords
- advanced lung cancer, Procrit, Epoetin Alfa, Ferric Gluconate, iron supplementation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped because of lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- May 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 4 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epoetin Alfa plus Iron | Experimental | Drug: Epoetin Alfa plus Iron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin Alfa plus IronAlso: Procrit®; Ferrlecit®1. One (1) injection of Procrit®, by needle, inserted just under the skin; 2. 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. | Drug | Epoetin Alfa plus Iron |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- James Graham Brown Cancer Center, Louisville, KYLink provided by the sponsor.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goetz H Kloecker, MD principal investigator
James Graham Brown Cancer Center, Univeristy of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epoetin Alfa plus Iron in people with Anemia, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.