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An Observational Study to Predict the Response of Erythropoietin Treatment in Participants With Cancer Related Anemia Receiving Chemotherapy

Information source: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia - Cancer Related

Intervention: Erythropoietin: Observational study (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Janssen-Cilag Ltd.,Thailand

Official(s) and/or principal investigator(s):
Janssen-Cilag Ltd.,Thailand Clinical Trial, Study Director, Affiliation: Janssen-Cilag Ltd.,Thailand


The purpose of this observational study is to evaluate the predictors of response to erythropoietin (hormone secreted by kidney that helps in formation of red blood cells in bone marrow) treatment in participants with cancer (abnormal tissue that grows and spreads in the body until it kills) related anemia (decreased number of red blood cells), receiving chemotherapy (treatment of cancer using drugs).

Clinical Details

Official title: Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Percentage of Participants With Response to Erythropoietin Treatment

Secondary outcome:

Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)

Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4

Serum Hemoglobin Level

Serum Hematocrit Level

Reticulocyte Count

Serum Ferritin Level

Serum Iron Level

Transferring Iron Binding Capacity (TIBC)

Detailed description: This is an observational, prospective (study following participants forward in time), multi-center (study conducted in more than 1 center) study to identify the predictive factors that will effectively predict the response to erythropoietin treatment in cancer related anemia participants receiving chemotherapy. The entire duration of study will be approximately 1 year. Participants will primarily be evaluated for achieving at least 1 gram per deciliter (g per dl) rise in hemoglobin (substance that carries oxygen and gives blood its red color) level after receiving erythropoietin treatment based on National Comprehensive Cancer Institute (NCCN) V3. 2009 practice guideline criteria. Response to erythropoietin treatment will also be predicted using other independent hematological

(related to blood) factors like C-reactive protein (CRP - is an acute serum protein released

from liver). It is associated with low hemoglobin [substance that carries oxygen and gives blood its red color] or erythropoietin [hormone secreted by kidney that helps in formation of red blood cells in bone marrow] resistance), erythropoietin (EPO), hemoglobin, hematocrit (amount of red blood cells in blood), reticulocyte (immature red blood cells) count, ferritin (a protein that stores iron and allows the body to use iron), serum iron (iron is in the blood which is bound to transferrin) and transferring iron binding capacity (TIBC), level. Number of blood transfusions and participants' safety will be monitored throughout the study.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Participants with non-hematologic malignancy (cancer or other progressively enlarging

and spreading tumor, usually fatal if not successfully treated)

- Participants with life expectancy of at least 6 months based on the Investigator's

clinical judgment

- Participants receiving chemotherapy

- Participants having indication and planning to receiving erythropoietin (dosage and

regimen should comply with Thai FDA approval package insert)

- Participants who have given consent form

Exclusion Criteria:

- Participants with anemia due to other factors (i. e., iron, B12 or folate

deficiencies, hemolysis [breakdown in red blood cells], gastrointestinal bleeding, or any active bleeding)

- Participants with previous history of erythropoietin treatment

- Participants who have received blood transfusion within 1 month before starting

erythropoietin therapy

- Pregnant or breast-feeding female participants

Locations and Contacts

Bangkok, Thailand

Chiang Mai, Thailand

Khon Kaen, Thailand

Additional Information

Starting date: November 2010
Last updated: March 28, 2014

Page last updated: August 23, 2015

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