A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy

Stopped early · Phase 2

Conditions studied: Neoplasms, Anemia, Cancer

In brief

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

Key facts

Study ID

NCT00386152

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

235

Starts

2006-11-01

Expected to finish

2008-05-01

Last updated by the study team

2013-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Bakersfield, California, United States
• Study site — Corona, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Fullerton, California, United States
• Study site — Greenbrae, California, United States
• Study site — Irvine, California, United States
• Study site — La Jolla, California, United States
• Study site — La Verne, California, United States
• Study site — Lancaster, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Northridge, California, United States
• Study site — Orange, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Denver, Colorado, United States
• Study site — Norwich, Connecticut, United States
• Study site — Gainsville, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Lecanto, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Athens, Georgia, United States
• Study site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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