Back to resultsA Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy.
Primary Purpose
Anemia, Neoplasms
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Epoetin Alfa
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia, Neoplasms, Hemoglobin values
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of non-myeloid malignancy Baseline hemoglobin value of less than or equal to 11 g/dL unrelated to transfusion Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable Female patients with reproductive potential must have a negative serum pregnancy test at screening. Exclusion Criteria: Uncontrolled hypertension History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder Transfusion within 28 days prior to first dose Planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months
Sites / Locations
Outcomes
Primary Outcome Measures
Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.
Secondary Outcome Measures
Secondary efficacy variables will include the effects of PROCRIT (Epoetin alfa) on transfusion requirements and on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) tool.
Full Information
NCT ID
NCT00350090
First Posted
July 7, 2006
Last Updated
May 17, 2011
Sponsor
Ortho Biotech Products, L.P.
1. Study Identification
Unique Protocol Identification Number
NCT00350090
Brief Title
A Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy.
Official Title
A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin Alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
This study was stopped early due to slow enrollment.
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ortho Biotech Products, L.P.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin alfa) administered at 40,000 Units weekly in cancer patients that are not receiving chemotherapy or radiation therapy.
Detailed Description
This is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy of PROCRIT (Epoetin alfa) with regard to hematopoietic response when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy. Hematological laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events will be assessed throughout the study. Patients will receive a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every week for a maximum of 13 weeks. Doses may be reduced depending on the patients' hemoglobin level.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Neoplasms
Keywords
Anemia, Neoplasms, Hemoglobin values
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Primary Outcome Measure Information:
Title
Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.
Secondary Outcome Measure Information:
Title
Secondary efficacy variables will include the effects of PROCRIT (Epoetin alfa) on transfusion requirements and on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) tool.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of non-myeloid malignancy
Baseline hemoglobin value of less than or equal to 11 g/dL unrelated to transfusion
Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
Female patients with reproductive potential must have a negative serum pregnancy test at screening.
Exclusion Criteria:
Uncontrolled hypertension
History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
Transfusion within 28 days prior to first dose
Planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ortho Biotech Products, L.P. Clinical Trial
Organizational Affiliation
Ortho Biotech Products, L.P.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16553139
Citation
Shasha D, Williams D. Weekly epoetin alfa treatment of anemia in patients with cancer not undergoing therapy. J Support Oncol. 2006 Mar;4(3):129-35.
Results Reference
result
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=928&filename=CR005113_CSR.pdf
Description
A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy or Radiation Therapy
Learn more about this trial
A Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy.
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