Alternate Dosing of PROCRIT (Epoetin Alfa) in Patients With Cancer and Chemotherapy Induced Anemia
An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients With Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)
1 other identifier
interventional
51
0 countries
N/A
Brief Summary
The purpose of this study was to test the effectiveness and safety of PROCRIT (Epoetin alfa) at a higher starting dose (60,000 Units) once per week, followed by a less frequent dose (60,000 Units every two weeks) in patients with cancer and chemotherapy induced anemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2003
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 16, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedMay 23, 2011
April 1, 2010
June 16, 2006
May 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with a >= 1 g/dL increase in Hb above baseline in Phase A independent of transfusion within 4 weeks
Secondary Outcomes (1)
Phase B: Maintain or increase the absolute Hb level achieved in Phase A (up to 0.9 g/dL higher) or maintain or increase the Hb level above that achieved in Phase A independent of transfusion within 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of non-myeloid malignancy (no history of myelodysplasia allowed) with a baseline hemoglobin of \<= 11 g/dL, planned to receive chemotherapy for a minimum of 12 weeks
- Life expectancy of \>= 6 months with an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
- Negative serum pregnancy test at Screening and adequate contraceptive during treatment and for three months after treatment
- Adequate hematologic function, adequate renal function and adequate hepatic function.
You may not qualify if:
- Planned radiation during the study
- Anemia due to factors other than cancer/chemotherapy (i.e., iron, B12 or folate deficiencies, hemolysis or gastrointestinal bleeding)
- Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa) within the previous three months
- Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy, uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
- Transfusion of platelets or packed red blood cells within 28 days prior to the first dose of study medication
- Planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell transplant during study duration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
- An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients with Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)
- \|Reddy PK; Williams D; Wilhelm FE. An Open-Label Pilot to Evaluate a Flexible Dosing Regimen of Epoetin Alfa for the Treatment of Chemotherapy-Induced Anemia: 60,000 Units Weekly Followed by 60,000 Units Every 2 Weeks
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 16, 2006
First Posted
June 20, 2006
Study Start
August 1, 2003
Study Completion
April 1, 2004
Last Updated
May 23, 2011
Record last verified: 2010-04