Status:
COMPLETED
Alternate Dosing of PROCRIT (Epoetin Alfa) in Patients With Cancer and Chemotherapy Induced Anemia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ever...
Detailed Description
This was an open-label, non-randomized, multicenter pilot study where patients who were receiving chemotherapy for non-myeloid malignancy (cancer) with a baseline hemoglobin (Hb) \<= 11 g/dL were enro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00338299
Start Date
August 1 2003
End Date
April 1 2004
Last Update
May 23 2011
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