A Study to Evaluate the Hematologic Response Rate (the Rate at Which the Hemoglobin Level Rises) of PROCRIT (Epoetin Alfa) Given at a Dose of 80,000 Units Once Weekly to Cancer Patients With Anemia Who Are Receiving Chemotherapy.

NCT00341055 | Completed Phase 3

• 1 other identifier: CR005110
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the hematologic response, safety, and clinical outcomes of PROCRIT administered once a week in anemic cancer patients receiving chemotherapy.

Conditions

Anemia; Cancer; Chemotherapy

Keywords

Anemia; Hemoglobin; Chemotherapy; Epoetin alfa

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint was major response defined as the proportion of patients with >= 2 g/dL hemoglobin (Hb) increase from baseline or Hb >= 12 g/dL and independent of transfusion within 28 days.

Secondary Outcomes (1)

• The secondary efficacy endpoint was minor response defined as the proportion of patients with >= 1 g/dL hemoglobin (Hb) increase from baseline (up to 1.9 g/dL increase) and incidence of transfusion and independent of transfusion within 28 days.

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 with a confirmed diagnosis of any non-myeloid malignancy planned to have received at least 12 weeks of chemotherapy with hemoglobin \<= 11 g/dL
• Life expectancy \> 6 months with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Both male and female patients with reproductive potential must have used an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment. Female patients with reproductive potential had a negative serum pregnancy test within 7 days of the first dose of study drug.

You may not qualify if:

• Previous radiation therapy to \> 25% bone marrow reserve or planned radiation during study duration
• Packed red blood cells (PRBC) transfusion within 28 days of study entry
• Anemia due to factors other than cancer/chemotherapy, i.e., iron, folate, Vitamin B12 deficiency, hemolysis or GI bleeding
• Previous treatment with Epoetin alfa or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin, novel erythropoiesis stimulating protein) within the previous 3 months
• uncontrolled hypertension or history of thrombotic vascular events

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 Hematologic Response Rate of PROCRIT (Epoetin alfa) at 80,000 Units Once Weekly in Anemic Cancer Patients Receiving Chemotherapy
• \|Waltzman RJ, Williams D, Braly P. A Pilot Study to Evaluate the Safety and Clinical Outcomes of Once-Weekly Epoetin Alfa 80,000 U in Anemic Patients With Cancer Receiving Chemotherapy. Supportive Cancer Therapy. 2005;3(1):47-53

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 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 1, 2003
• Study Completion: May 1, 2004
• Last Updated: June 10, 2011

Record last verified: 2010-03