Clinical trial NCT00386152: A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy
Official title: A Randomized, Open-Label, Comparative Study of Epoetin Alfa (PROCRIT) 80,000 Units or 120,000 Units Q3W (Every 3 Weeks) Versus Darbepoetin Alfa (ARANESP) 500 Mcg Q3W in Anemic Cancer Subjects Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neoplasms
Anemia
Cancer
Keywords: Anemia
Cancer
Chemotherapy-Induced Anemia
Epoetin alfa
Darbepoetin alfa
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Ortho Biotech Clinical Affairs, L.L.C.
First posted: 2006-10-11
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Hemoglobin (Hb) Change From Baseline to Study Week 7
timeFrame: Baseline (Week 1) and Week 7
Secondary outcomes:
measure: Number of Patients Receiving at Least 1 Packed Red Blood Cell (PRBC) Transfusion During Study
timeFrame: up to 16 weeks
measure: Time to Achieve Hb >= 11 g/dL During Study
timeFrame: up to 16 weeks
measure: Number of Patients (Hb >= 11 g/dL) During Study.
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Glendale
country: United States
state: Arizona
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: Corona
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Greenbrae
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: La Verne
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Northridge
country: United States
state: California
city: Orange
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Norwich
country: United States
state: Connecticut
city: Gainsville
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Lecanto
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Athens
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Griffin
country: United States
state: Georgia
city: Centralia
country: United States
state: Illinois
city: Gurnee
country: United States
state: Illinois
city: North Chicago
country: United States
state: Illinois
city: Olympia Fields
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: New Albany
country: United States
state: Indiana
city: Hutchinson
country: United States
state: Kansas
city: Kansas City
country: United States
state: Kansas
city: Paducah
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Bethesda
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Free Soil
country: United States
state: Michigan
city: Lansing
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Tupelo
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Englewood
country: United States
state: New Jersey
city: Clifton Springs
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Canton
country: United States
state: Ohio
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pottsville
country: United States
state: Pennsylvania
city: Aiken
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Mt Pleasant
country: United States
state: South Carolina
city: N Charleston
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Johnson City
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Bryan
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Grapevine
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Newport News
country: United States
state: Virginia
city: Woodbridge
country: United States
state: Virginia
city: Vancouver
country: United States
state: Washington
city: Walla Walla
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: