- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210600
Early and Standard Intervention With 120,000 Units of PROCRIT (Epoetin Alfa) Every Three Weeks in Patients Receiving Chemotherapy
Assessment of Early and Standard Intervention With PROCRIT (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy.
Study Overview
Detailed Description
This is a randomized, open-label, multi-center study. Eligible patients will be identified during the screening phase. After randomization, the Treatment Phase will start at the Day 1, Week 1 visit. The entire study period will be up to 22 weeks, with the screening phase lasting up to two weeks, treatment for a maximum of 16 weeks, and safety follow-up for four weeks. The primary objective of this study is to obtain efficacy and safety data regarding PROCRIT (Epoetin alfa) administered at 120,000 units subcutaneously (sc) once every three weeks (q3w) in 2 patient groups with cancer and anemia receiving chemotherapy:
- Early Intervention Group: PROCRIT (Epoetin alfa) treatment started at patient hemoglobin (Hb) >= 11.0 g/dL to <= 12.0 g/dL and
- Standard Intervention Group: PROCRIT (Epoetin alfa) treatment started once patient hemoglobin drops to < 11 g/dL or has a Hb <11.0 g/dL at study entry.
For safety monitoring, all patients will be followed for adverse events, hemoglobin (Hb), hematocrit (Hct), blood chemistries and blood pressure measurements throughout the study. All eligible patients with hemoglobin < 12.0 g/dL will be randomized to receive Epoetin alfa injections (120,000 Units ) under the skin every 3 weeks for a maximum of 16 treatment weeks. Doses may be adjusted depending on the patients hemoglobin levels.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Biopsy confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin (Hb) value of >= 11.0 g/dL and <= 12.0 g/dL
- No blood transfusions in the 28 days prior to the start of Treatment Phase
- Must be receiving chemotherapy or will begin receiving chemotherapy at start of Treatment
- Iron transferrin saturation (TSAT) > 20% or if TSAT<20%, serum ferritin must be greater than 100 ng/mL.
Exclusion Criteria:
- No myeloid malignancy or known history of myelodysplasia
- No planned radiation during the study
- Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa, gene-activated erythropoietin) within the previous three months
- No uncontrolled disease/dysfunction of the lung, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems
- No history of uncontrolled cardiac arrhythmias (within 6 months) or pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic hypercoagulable disorders
- Has not received an experimental drug or device within the past 30 days
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The proportion of weekly hemoglobin levels for all patients in each group during the 16 week PROCRIT (Epoetin alfa) treatment that are > 11.0 g/dL and < 13.0 g/dL.
|
Secondary Outcome Measures
Outcome Measure |
---|
The proportion of patients in the early intervention group for whom all hemoglobin values during the 16 week PROCRIT (Epoetin alfa) treatment were > 11.0 g/dL and < 13.0 g/dL.
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR003196
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia
-
SanofiActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)United States, Austria, China, Denmark, Germany, Hungary, Italy, Spain, United Kingdom
-
SanofiTerminatedWarm Autoimmune Hemolytic Anemia (wAIHA)United Kingdom, Belgium, Netherlands, France, United States, Germany, Hungary, Italy
-
Hospital Universitario Dr. Jose E. GonzalezCompletedPernicious Anemia | Megaloblastic Anemia NosMexico
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSevere Aplastic Anemia | Idiopathic Aplastic Anemia | Moderate Aplastic Anemia Requiring Transfusions
-
Abdelwahed, Mai Mahmoud Mohamed, M.D.UnknownAnemia During PregnancyEgypt
-
University of California, DavisInstituto Mexicano del Seguro Social; Thrasher Research Fund; Mexican National... and other collaboratorsCompleted
-
Incyte CorporationActive, not recruitingWarm Autoimmune Hemolytic Anemia (wAIHA)Spain, United States, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Poland, United Kingdom
-
Cornell UniversityUniversity of California, Los AngelesCompletedPregnancy Anemia | Newborn; AnemiaUnited States
-
Peking Union Medical College HospitalRecruiting
Clinical Trials on PROCRIT (Epoetin alfa)
-
M.D. Anderson Cancer CenterCompleted
-
University of South FloridaOrtho Biotech, Inc.TerminatedSubarachnoid HemorrhageUnited States
-
Washington University School of MedicineNational Institute of Neurological Disorders and Stroke (NINDS); PPD; Ortho Biotech...WithdrawnHIV Infections | Neuropathy
-
National Institute on Aging (NIA)CompletedAcute ST Elevation Myocardial InfarctionUnited States
-
Stanford UniversityNational Institute on Aging (NIA)Withdrawn
-
M.D. Anderson Cancer CenterOrtho PharmaceuticalsTerminatedRectal Cancer | Gastrointestinal CancerUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Clinical Affairs, L.L.C.TerminatedNeoplasms | Cancer | AnemiaUnited States
-
Johnson & Johnson Pharmaceutical Research & Development...Ortho Biotech Clinical Affairs, L.L.C.Terminated
-
Mehrotra, Anita, M.D.Icahn School of Medicine at Mount SinaiTerminated
-
Johnson & Johnson Pharmaceutical Research & Development...Completed