AnemiaPhase 3NCT00261677
A Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) or Placebo on Anemia and Quality of Life in Children With Cancer Undergoing Chemotherapy
A Phase 3 study testing epoetin alfa in people with Anemia and Hodgkin Disease, run by Ortho Biotech Products, L.P..
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRIT® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Anemia, Hodgkin Disease, Leukemia
- What is being tested?
- epoetin alfa
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Oct 2003
- Phase
- Phase 3
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a confirmed new diagnosis of malignant solid tumor, Hodgkin's disease, Acute Lymphocytic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL)
- scheduled to receive first myelosuppressive chemotherapy within 7 days of baseline or have received up to the second myelosuppressive chemotherapy within 60 days prior to study enrollment, and scheduled to receive chemotherapy over a minimum period of 12 weeks after study enrollment
- anemic according to age-based and gender-based criteria (hemoglobin level of < 10.5 g/dL for boys and girls ages 5 to 12 years, < 11.0 g/dL for girls older than 12 years, < 12.0 g/dL for boys older than 12 years)
- have an indwelling central venous access device (e.g., subcutaneous port, external Hickman-Broviac-type catheter, or peripherally inserted central catheter) or existing peripheral intravenous catheter in place for chemotherapy administration
- both male or female patients who are reproductive potential and sexually active must be practicing an acceptable method of birth control throughout the entire study
- Parent/legal guardian must have read and signed the informed consent and patients must have provided assent, as appropriate according to state and IRB requirements
Who cannot join
- Diagnosis of myeloid leukemia or other myeloid malignancy (e.g., granulocytic sarcoma)
- diagnosis of Down's Syndrome, tumor of the central nervous system (CNS) or symptomatic metastatic CNS disease (for the solid tumor/Hodgkin's Disease stratum), or presence of symptomatic CNS disease at diagnosis (for the Acute Lymphocytic Leukemia/Non-Hodgkin's Lymphoma stratum)
- scheduled to receive cranial irradiation during the study period, or has received cranial irradiation within 30 days prior to study enrollment
- have an inherited form of anemia (hemoglobinopathy, thalassemia, red cell membrane defect, red cell enzyme deficiency) or a Coombs-positive hemolytic anemia
- elevated serum creatinine based upon age of study entry ( > 0.8 mg/dL for children younger than 10 years, > 1.1 mg/dL for children 10 - 15 years, > 1.4 mg/dL for children older than 15 years)
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) on Anemia and Quality of Life in Children With Cancer Undergoing Myelosuppressive Chemotherapy
The purpose of this study is to evaluate the safety and effectiveness of once- weekly dosing of PROCRIT® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life.
Read the detailed description
PROCRIT® (epoetin alfa) is an analogue of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. PROCRIT® is approved to be given three times per week to treat anemia in adult cancer patients receiving chemotherapy. Once per week dosing in adult cancer patients receiving chemotherapy is investigational and is not approved by the FDA. The use of PROCRIT® in children with cancer is investigational and is not approved by the FDA. (Please note: Since completion of this study, once weekly dosing on PROCRIT® in adult cancer patients was approved by FDA in June 2004 and use of PROCRIT® in children with cancer was approved by FDA in October 2005). The use of PROCRIT® to improve quality of life is investigational and not approved by the FDA. This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of once-weekly dosing of PROCRIT® or placebo on anemia in children with cancer undergoing myelosuppressive chemotherapy, and to assess its effect on the quality of life. Patients are randomized into a 1:1 ratio to receive either PROCRIT® or placebo administered intravenously. Randomization is stratified by cancer type, with one stratum for children diagnosed with a malignant solid tumor or Hodgkin's Disease, and the second stratum for children diagnosed with Acute Lymphocytic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL). The initial dose of study medication is 600 Units/kg for a maximum dose of 40,000 Units intravenously (IV) weekly, or placebo, up to 16 weeks. The study medication is adjusted to 900 Units/kg, for a maximum dose of 60,000 Units IV weekly, if the hemoglobin does not increase by at least 1 g/dL by Study Week 4/5. Patients were seen and evaluated based on the patient's scheduled chemotherapy regimen. Patients who received chemotherapy weekly, every two weeks, or every four weeks (4-week group), scheduled study visits occurred every four weeks. The study investigated effectiveness of once weekly dosing of PROCRIT® on anemia and quality of life in children with cancer undergoing myelosuppressive chemotherapy. The primary measure of effectiveness is the change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment. Other measures of effectiveness include differences in hemoglobin levels, transfusion requirements, and quality of life outcomes. Safety is assessed by comparing the incidence and severity of adverse experiences in the PROCRIT® group versus the placebo group. Clinical laboratory tests (hematology, iron profile, and serum chemistry), physical examinations, and vital sign measurements are also assessed. 600 to 900 Units/kg intravenously (IV) of either PROCRIT® or placebo. Initial dose is 600 Units/kg (maximum dose 40,000 Units IV weekly) up to 16 weeks. If the hemoglobin does not increase by >= 1 g/dL at Week 4/5, dose is adjusted to 900 Units/kg (maximum dose 60,000 Units IV weekly).
- Conditions
- Anemia, Hodgkin Disease, Leukemia, Lymphoma, Non-hodgkin
- Being tested
- epoetin alfa
- Keywords
- Anemia, cancer, solid tumor, Hodgkin's Disease, Acute Lymphocytic Leukemia (ALL), Non-Hodgkin's Lymphoma (NHL), Quality of Life, hemoglobin, Epoetin alfa
- Medical subject headings
- Anemia, Hodgkin Disease, Leukemia, Lymphoma, Non-Hodgkin, Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
Secondary outcomes (1)
Parents' Quality of Life assessments on the Pediatric Quality of Life Inventory (PedsQL Inventory); Patient- and parent-reported assessments on the PedsQL Cancer Module; hemoglobin levels; transfusion requirements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startAug 2000
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Biotech Products, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho Biotech Products, L.P. Clinical Trial, Study director, Ortho Biotech Products, L.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261677
- Sponsor's protocol ID
- CR002296
- Status last verified
- Apr 2010
- First submitted
- 2 Dec 2005
- Last updated
- 23 May 2011
- Results posted
- No
Publications
Razzouk BI, Hord JD, Hockenberry M, Hinds PS, Feusner J, Williams D, Rackoff WR. Double-blind, placebo-controlled study of quality of life, hematologic end points, and safety of weekly epoetin alfa in children with cancer receiving myelosuppressive chemotherapy. J Clin Oncol. 2006 Aug 1;24(22):3583-9. doi: 10.1200/JCO.2005.03.4371.
PubMed 16877725
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) on Anemia and Quality of Life in Children With Cancer Undergoing Myelosuppressive Chemotherapy
- ClinicalTrials.gov ID
- NCT00261677
- Acronym / sponsor ID
- CR002296
- Conditions
- Anemia, Hodgkin Disease, Leukemia, Lymphoma, Non-hodgkin
- Keywords
- Anemia, cancer, solid tumor, Hodgkin's Disease, Acute Lymphocytic Leukemia (ALL), Non-Hodgkin's Lymphoma (NHL), Quality of Life, hemoglobin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Aug 2000
- Study completion
- Oct 2003 (actual)
- First posted
- 5 Dec 2005 (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 evaluate the safety and effectiveness of once- weekly dosing of PROCRIT® (a glycoprotein that stimulates red blood cell production) versus placebo in the treatment of anemia in children with cancer undergoing chemotherapy, and to assess its effect on the quality of life.
Detailed description
PROCRIT® (epoetin alfa) is an analogue of erythropoetin, a hormone secreted by kidneys known to stimulate red blood cell production. PROCRIT® is approved to be given three times per week to treat anemia in adult cancer patients receiving chemotherapy. Once per week dosing in adult cancer patients receiving chemotherapy is investigational and is not approved by the FDA. The use of PROCRIT® in children with cancer is investigational and is not approved by the FDA. (Please note: Since completion of this study, once weekly dosing on PROCRIT® in adult cancer patients was approved by FDA in June 2004 and use of PROCRIT® in children with cancer was approved by FDA in October 2005). The use of PROCRIT® to improve quality of life is investigational and not approved by the FDA. This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of once-weekly dosing of PROCRIT® or placebo on anemia in children with cancer undergoing myelosuppressive chemotherapy, and to assess its effect on the quality of life. Patients are randomized into a 1:1 ratio to receive either PROCRIT® or placebo administered intravenously. Randomization is stratified by cancer type, with one stratum for children diagnosed with a malignant solid tumor or Hodgkin's Disease, and the second stratum for children diagnosed with Acute Lymphocytic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL). The initial dose of study medication is 600 Units/kg for a maximum dose of 40,000 Units intravenously (IV) weekly, or placebo, up to 16 weeks. The study medication is adjusted to 900 Units/kg, for a maximum dose of 60,000 Units IV weekly, if the hemoglobin does not increase by at least 1 g/dL by Study Week 4/5. Patients were seen and evaluated based on the patient's scheduled chemotherapy regimen. Patients who received chemotherapy weekly, every two weeks, or every four weeks (4-week group), scheduled study visits occurred every four weeks. The study investigated effectiveness of once weekly dosing of PROCRIT® on anemia and quality of life in children with cancer undergoing myelosuppressive chemotherapy. The primary measure of effectiveness is the change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment. Other measures of effectiveness include differences in hemoglobin levels, transfusion requirements, and quality of life outcomes. Safety is assessed by comparing the incidence and severity of adverse experiences in the PROCRIT® group versus the placebo group. Clinical laboratory tests (hematology, iron profile, and serum chemistry), physical examinations, and vital sign measurements are also assessed. 600 to 900 Units/kg intravenously (IV) of either PROCRIT® or placebo. Initial dose is 600 Units/kg (maximum dose 40,000 Units IV weekly) up to 16 weeks. If the hemoglobin does not increase by >= 1 g/dL at Week 4/5, dose is adjusted to 900 Units/kg (maximum dose 60,000 Units IV weekly).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with a confirmed new diagnosis of malignant solid tumor, Hodgkin's disease, Acute Lymphocytic Leukemia (ALL) or Non-Hodgkin's Lymphoma (NHL)
- scheduled to receive first myelosuppressive chemotherapy within 7 days of baseline or have received up to the second myelosuppressive chemotherapy within 60 days prior to study enrollment, and scheduled to receive chemotherapy over a minimum period of 12 weeks after study enrollment
- anemic according to age-based and gender-based criteria (hemoglobin level of < 10.5 g/dL for boys and girls ages 5 to 12 years, < 11.0 g/dL for girls older than 12 years, < 12.0 g/dL for boys older than 12 years)
- have an indwelling central venous access device (e.g., subcutaneous port, external Hickman-Broviac-type catheter, or peripherally inserted central catheter) or existing peripheral intravenous catheter in place for chemotherapy administration
- both male or female patients who are reproductive potential and sexually active must be practicing an acceptable method of birth control throughout the entire study
Key exclusion criteria (5 listed)
- Diagnosis of myeloid leukemia or other myeloid malignancy (e.g., granulocytic sarcoma)
- diagnosis of Down's Syndrome, tumor of the central nervous system (CNS) or symptomatic metastatic CNS disease (for the solid tumor/Hodgkin's Disease stratum), or presence of symptomatic CNS disease at diagnosis (for the Acute Lymphocytic Leukemia/Non-Hodgkin's Lymphoma stratum)
- scheduled to receive cranial irradiation during the study period, or has received cranial irradiation within 30 days prior to study enrollment
- have an inherited form of anemia (hemoglobinopathy, thalassemia, red cell membrane defect, red cell enzyme deficiency) or a Coombs-positive hemolytic anemia
- elevated serum creatinine based upon age of study entry ( > 0.8 mg/dL for children younger than 10 years, > 1.1 mg/dL for children 10 - 15 years, > 1.4 mg/dL for children older than 15 years)
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 | Drug | – |
Primary outcome
Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
1 secondary outcome
Parents' Quality of Life assessments on the Pediatric Quality of Life Inventory (PedsQL Inventory); Patient- and parent-reported assessments on the PedsQL Cancer Module; hemoglobin levels; transfusion requirements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2011.
- Results publication: PubMed 16877725Razzouk BI, Hord JD, Hockenberry M, Hinds PS, Feusner J, Williams D, Rackoff WR. Double-blind, placebo-controlled study of quality of life, hematologic end points, and safety of weekly epoetin alfa in children with cancer receiving myelosuppressive chemotherapy. J Clin Oncol. 2006 Aug 1;24(22):3583-9. doi: 10.1200/JCO.2005.03.4371.
- Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Weekly PROCRIT (Epoetin Alfa) on Anemia and Quality of Life in Children with Cancer Undergoing Myelosuppressive ChemotherapyLink provided by the sponsor.
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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.
Ortho Biotech Products, L.P. Clinical Trial study director
Ortho Biotech Products, L.P.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa in people with Anemia and Hodgkin Disease, run by Ortho Biotech Products, L.P..
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 23 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00261677, which also lists 1 linked publication.
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 23 May 2011.