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

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Anemia - Cancer Related

Treatments: Drug: Erythropoietin: Observational study

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01736215

CR016558

EPOCAN4028

Details and patient eligibility

About

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).

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

33 participants in 1 patient group

Participants with cancer related anemia

Description:

Participants with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.

Treatment:

Drug: Erythropoietin: Observational study