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

NCT ID: NCT00386152

Last Updated: 2013-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-05-31

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 (patients are assigned to a specific study group by chance) to one of three treatment groups in a 1:1:1 ratio. Patients will receive PROCRIT (epoetin alfa) 80,000 Units injected subcutaneously (under the skin) once every three weeks or 120,000 Units injected under the skin once every three weeks or ARANESP (darbepoetin alfa) 500 mcg injected under the skin once every three weeks for up to 13 weeks. PROCRIT (epoetin alfa) 80,000 Units and 120,000 Units given once every three weeks are doses and schedules that are not approved for use in the United States and are under investigation, while the ARANESP dose and schedule are approved for use in the United States. Adult patients with specific types of cancer (confirmed non-myeloid malignancy) who are scheduled to receive cyclic chemotherapy for a minimum of 12 weeks during the study and who meet all other eligibility criteria will be enrolled. This study will be conducted in approximately 80 study sites located in the United States.

The study hypothesis is that a dosing regimen of PROCRIT (Epoetin alfa) 80,000 Units or 120,000 Units given once every three weeks is non-inferior to ARANESP 500 mcg given once every three weeks with respect to the mean hemoglobin (Hb) change from baseline to Study Week 7 in anemic cancer patients receiving chemotherapy. Hemoglobin levels will be monitored throughout the study on a weekly basis and before each drug dose is administered. Drug dosing will be adjusted (ie, held, reduced, resumed at a lower dose) as needed to maintain hemoglobin values within desired ranges.

The maximum dose of PROCRIT (Epoetin alfa) allowed in this study is 120,000 Units every three weeks (Q3W) and the maximum dose of ARANESP (darbepoetin) is 500 mcg Q3W.

Safety evaluations will be conducted throughout the study and will consist of assessment of laboratory tests, vital signs, physical examinations. The occurrence and severity of adverse events, including thrombovascular events will be evaluated throughout the study.Periodic data monitoring of the study by an external Independent Data Monitoring Committee (IDMC) will be performed. The main responsibility of the IDMC is to conduct ongoing monitoring of safety and to report any irregularities back to the Sponsor along with recommendations regarding continuation of the study. Each patient will be assigned to one of three dosing schedules. All schedules will be administered by way of subcutaneous (under the skin) injection once every three weeks over a period of 13 weeks. The three dosing schedules are as follows: PROCRIT (epoetin alfa) 80,000 Units, PROCRIT (epoetin alfa) 120,000 Units or ARANESP (darbepoetin alfa) 500 mcg

Conditions

Neoplasms; Anemia; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

epoetin alfa (120,000 Units)

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

Group Type: EXPERIMENTAL

epoetin alfa

Intervention Type: DRUG

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

epoetin alfa (80,000 Units)

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

Group Type: EXPERIMENTAL

epoetin alfa

Intervention Type: DRUG

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

darbepoetin alfa (500 mcg)

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

Group Type: ACTIVE_COMPARATOR

darbepoetin alfa

Intervention Type: DRUG

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

Interventions

epoetin alfa

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

Intervention Type: DRUG

darbepoetin alfa

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

Intervention Type: DRUG

Other Intervention Names

PROCRIT; ARANESP

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech Clinical Affairs, L.L.C.

INDUSTRY

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

Glendale, Arizona, United States

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

Anaheim, California, United States

Bakersfield, California, United States

Corona, California, United States

Fountain Valley, California, United States

Fullerton, California, United States

Greenbrae, California, United States

Irvine, California, United States

La Jolla, California, United States

La Verne, California, United States

Lancaster, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Northridge, California, United States

Orange, California, United States

Rancho Mirage, California, United States

Denver, Colorado, United States

Norwich, Connecticut, United States

Gainsville, Florida, United States

Kissimmee, Florida, United States

Lecanto, Florida, United States

Pensacola, Florida, United States

Athens, Georgia, United States

Augusta, Georgia, United States

Griffin, Georgia, United States

Centralia, Illinois, United States

Gurnee, Illinois, United States

North Chicago, Illinois, United States

Olympia Fields, Illinois, United States

Park Ridge, Illinois, United States

Springfield, Illinois, United States

New Albany, Indiana, United States

Hutchinson, Kansas, United States

Kansas City, Kansas, United States

Paducah, Kentucky, United States

Baltimore, Maryland, United States

Bethesda, Maryland, United States

Worcester, Massachusetts, United States

Free Soil, Michigan, United States

Lansing, Michigan, United States

Southfield, Michigan, United States

Tupelo, Mississippi, United States

Kansas City, Missouri, United States

Omaha, Nebraska, United States

Englewood, New Jersey, United States

Clifton Springs, New York, United States

Lake Success, New York, United States

Asheville, North Carolina, United States

Wilmington, North Carolina, United States

Bismarck, North Dakota, United States

Canton, Ohio, United States

Lancaster, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pottsville, Pennsylvania, United States

Aiken, South Carolina, United States

Charleston, South Carolina, United States

Mt. Pleasant, South Carolina, United States

North Charleston, South Carolina, United States

Sumter, South Carolina, United States

Johnson City, Tennessee, United States

Memphis, Tennessee, United States

Bryan, Texas, United States

El Paso, Texas, United States

Galveston, Texas, United States

Grapevine, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Tyler, Texas, United States

Chesapeake, Virginia, United States

Newport News, Virginia, United States

Woodbridge, Virginia, United States

Vancouver, Washington, United States

Walla Walla, Washington, United States

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

EPOANE2007

Identifier Type: OTHER

Identifier Source: secondary_id

CR012985

Identifier Type: -

Identifier Source: org_study_id