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Anemia in Patients With a Non-Myeloid Malignancy

NCT ID: NCT00038064

Last Updated: 2008-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

707 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2004-04-30

Brief Summary

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Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.

Detailed Description

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Conditions

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Neoplasms Anemia

Keywords

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anemia of cancer/chemotherapy non-myeloid malignancies Drug Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rHuEPO

Group Type ACTIVE_COMPARATOR

rHuEPO

Intervention Type DRUG

150 IU/kg TIW

Darbepoetin alfa

Group Type EXPERIMENTAL

Darbepoetin alfa

Intervention Type DRUG

Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.

Interventions

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Darbepoetin alfa

Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.

Intervention Type DRUG

rHuEPO

150 IU/kg TIW

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug
* Screening hemoglobin concentration less than or equal to 11.0 g/dL
* ECOG performance status of 0 to 2 (inclusive)

Exclusion Criteria

* History of seizure disorder
* Primary hematologic disorder that could cause anemia
* Unstable or uncontrolled disease/condition related to or affecting cardiac function
* Clinical evidence of chronic infection/inflammatory disease
* Positive test for HIV infection
* Previously confirmed neutralizing antibodies to rHuEPO
* Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf

Notice regarding posted summaries of trial results

http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20010101.pdf

To access clinical trial results information click on this link

http://www.aranesp.com/

FDA-approved Drug Labeling

Other Identifiers

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20010101

Identifier Type: -

Identifier Source: org_study_id

NCT00046982

Identifier Type: -

Identifier Source: nct_alias