Status:
TERMINATED
A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Clinical Affairs, L.L.C.
Conditions:
Neoplasms
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare hemoglobin response rates between two PROCRIT (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving chemotherapy
Detailed Description
This is an open-label (both the physician and the patient know which treatment is being provided), multi-center study of up to 16 weeks duration in which 450 patients will be randomly assigned (patien...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of a non-myeloid malignancy
- Baseline hemoglobin (Hb) value of \<= 11.0 g/dL unrelated to transfusion
- No Packed Red Blood Cell (PRBC) or platelet transfusions in the 28 days prior to randomization
- Scheduled to receive chemotherapy for a minimum of 12 weeks during the study
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
Exclusion
- No planned non-palliative radiation during the study
- No current anemia due to factors other than cancer/chemotherapy (eg, iron deficiency or gastrointestinal bleeding)
- No uncontrolled hypertension (defined as systolic pressure \> 180 and/or a diastolic pressure \> 100 mmHg while receiving antihypertension therapy)
- No history of Deep Venous Thrombosis (DVT) or Pulmonary Embolus (PE) within 12 months before study enrollment. Prior superficial thrombophlebitis is not an exclusion criterion
- No history of Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Acute Coronary Syndrome (ACS) including unstable angina and myocardial infarction with or without ST elevation, or other arterial thrombosis within 6 months before study enrollment
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT00386152
Start Date
November 1 2006
End Date
May 1 2008
Last Update
July 19 2013
Active Locations (76)
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1
Glendale, Arizona, United States
2
Jonesboro, Arkansas, United States
3
Little Rock, Arkansas, United States
4
Anaheim, California, United States