A Study of PROCRIT (Epoetin Alfa) 80,000 Units (U) Once Every Four Weeks (Q4W) vs. 40,000 U Once Every Two Weeks (Q2W) in Cancer Patients Not Receiving Chemotherapy

NCT00306267 | Terminated Phase 2

• 1 other identifier: CR010540
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety and effectiveness of PROCRIT (Epoetin alfa) administered by injection subcutaneously (SC, under the skin), at a dose of 80,000 U once every four weeks or 40,000 U once every two in anemic patients with cancer not receiving chemotherapy or radiation therapy.

Conditions

Anemia; Cancer; Epoetin Alfa

Keywords

Anemia; non-chemotherapy-induced; non-radiation therapy-induced; cancer; non-myeloid

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint will be hematopoietic response, defined as >= 1 g/dL rise in hemoglobin from baseline.

Secondary Outcomes (1)

• Secondary objectives are to assess the two dosing regimens on time-to-hematopoietic response and transfusion requirements. Safety assessments will include laboratory tests, blood pressure, physical examination and severity of adverse events.

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have "Active non-myeloid cancer malignancy" or incurable cancer with a life expectancy of 6 months or more
• Patients may also have had cancer treatment within the past 2 years but no chemotherapy or radiation therapy within the past 8 weeks prior to enrollment
• must be \>= 18 years of age and must not be receiving or planning to receive cytotoxic chemotherapy or external beam radiotherapy during the study period
• must have a baseline Hb \<= 11 g/dL.
• Patients with reproductive potential must be practicing an effective method of birth control and women cannot be pregnant or breast-feeding during the study period
• Patients must be able to comply with all requirements of the study (i.e. study visit schedules) and patients (or their legally authorized representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

You may not qualify if:

• Patients receiving or planning to receive chemotherapy or radiation therapy within 8 weeks of study entry
• Anemia due to factors other than cancer
• Previous treatment with epoetin alfa or any form of erythropoietin during the previous 1 month or received an experimental drug or device within past 30 days
• Known hypersensitivity to mammalian-cell derived products or to human albumin
• Untreated known central nervous system (CNS) metastases
• Uncontrolled or clinically severe disease of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy
• History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE), or other venous thrombotic events, cerebrovascular accident (CVA), transient ischemic attack (TIA), Acute Coronary Syndrome (ACS) \[unstable angina, myocardial infarction (MI)\], or other arterial thrombosis
• Currently receiving therapeutic or prophylactic anticoagulants
• Transfusion of packed red blood cells within 28 days prior to the first dose of study drug, or planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell transplant during study duration.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech Products, L.P.: collaborator

Related Links

• A Pilot Study to Evaluate the Safety and Efficacy of PROCRIT� (epoetin alfa) 80,000 Units Once Every 4 Weeks (q4w) vs. 40,000 Units Once Every 2 Weeks (q2w) in Cancer Subjects With Non-Chemotherapy Anemia (NCA)

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 23, 2006
• Study Start: March 1, 2006
• Study Completion: May 1, 2007
• Last Updated: May 18, 2011

Record last verified: 2010-03