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

NCT00386152 | Terminated Phase 2 Results DMC

• 2 other identifiers: CR012985EPOANE2007
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 76

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

Conditions

Neoplasms; Anemia; Cancer

Keywords

Anemia; Cancer; Chemotherapy-Induced Anemia; Epoetin alfa; Darbepoetin alfa

Outcome Measures

Primary Outcomes (1)

• Hemoglobin (Hb) Change From Baseline to Study Week 7

  Baseline Hb was the Hb value that was consistent with the inclusion criteria and which was obtained within 72 hours of the first dose of study medication

  Baseline (Week 1) and Week 7

Secondary Outcomes (3)

• Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study

  up to 16 weeks

• Time to Achieve Hb >= 11 g/dL During Study

  up to 16 weeks

• Number of Patients (Hb >= 11 g/dL) During Study.

  up to 16 weeks

Study Arms (3)

epoetin alfa (120,000 Units)

EXPERIMENTAL

epoetin alfa (PROCRIT) 120,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks

Drug: epoetin alfa

epoetin alfa (80,000 Units)

EXPERIMENTAL

epoetin alfa (PROCRIT) 80,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks

Drug: epoetin alfa

darbepoetin alfa (500 mcg)

ACTIVE COMPARATOR

darbepoetin alfa (ARANESP) 500 mcg injected subcutaneously the skin once every 3 weeks for up to 13 weeks

Drug: darbepoetin alfa

Interventions

epoetin alfa DRUG

80,000 Units and 120,000 Units of epoetin alfa (PROCRIT) injected subcutaneously once every 3 weeks for up to 13 weeks

Also known as: PROCRIT

epoetin alfa (120,000 Units); epoetin alfa (80,000 Units)

darbepoetin alfa DRUG

500 mcg of darbepoetin alfa (ARANESP) injected subcutaneously the skin once every 3 weeks for up to 13 weeks

Also known as: ARANESP

darbepoetin alfa (500 mcg)

Eligibility Criteria

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

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 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech Clinical Affairs, L.L.C.: collaborator

Study Sites (76)

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Glendale, Arizona, United States

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Jonesboro, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Corona, California, United States

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Fountain Valley, California, United States

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Fullerton, California, United States

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Greenbrae, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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La Verne, California, United States

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Lancaster, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Orange, California, United States

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Rancho Mirage, California, United States

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Denver, Colorado, United States

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Norwich, Connecticut, United States

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Gainsville, Florida, United States

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Kissimmee, Florida, United States

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Lecanto, Florida, United States

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Pensacola, Florida, United States

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Athens, Georgia, United States

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Augusta, Georgia, United States

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Griffin, Georgia, United States

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Centralia, Illinois, United States

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Gurnee, Illinois, United States

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North Chicago, Illinois, United States

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Olympia Fields, Illinois, United States

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Park Ridge, Illinois, United States

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Springfield, Illinois, United States

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New Albany, Indiana, United States

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Hutchinson, Kansas, United States

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Kansas City, Kansas, United States

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Paducah, Kentucky, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Worcester, Massachusetts, United States

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Free Soil, Michigan, United States

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Lansing, Michigan, United States

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Southfield, Michigan, United States

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Tupelo, Mississippi, United States

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Kansas City, Missouri, United States

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Omaha, Nebraska, United States

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Englewood, New Jersey, United States

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Clifton Springs, New York, United States

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Lake Success, New York, United States

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Asheville, North Carolina, United States

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Wilmington, North Carolina, United States

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Bismarck, North Dakota, United States

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Canton, Ohio, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pottsville, Pennsylvania, United States

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Aiken, South Carolina, United States

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Charleston, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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North Charleston, South Carolina, United States

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Sumter, South Carolina, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, United States

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Bryan, Texas, United States

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El Paso, Texas, United States

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Galveston, Texas, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Chesapeake, Virginia, United States

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Newport News, Virginia, United States

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Woodbridge, Virginia, United States

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Vancouver, Washington, United States

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Walla Walla, Washington, United States

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Morgantown, West Virginia, United States

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MeSH Terms

Conditions

Neoplasms; Anemia

Interventions

Epoetin Alfa; Darbepoetin 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

Limitations and Caveats

Due to the significantly reduced power (stopped prematurely when 235 patients enrolled), all protocol-specified hypothesis tests were not performed. Instead, desriptive statistics were presented for each of the endpoints by treatment group.

Results Point of Contact

• Title: Nephrology Therapeutic Area, Medical Lead
• Organization: Centocor Ortho Biotech Services, LLC

215-325-4176

Study Officials

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

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 19, 2013
• Results First Posted: June 1, 2009

Record last verified: 2013-07

Locations

US (76)