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

This study has been terminated.
(This study was terminated regarding to slow enrollment.)
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier:
NCT01736215
First received: November 26, 2012
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention Phase
Anemia - Cancer Related
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients Receiving Chemotherapy

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.,Thailand:

Primary Outcome Measures:
  • Percentage of Participants With Response to Erythropoietin Treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria.


Secondary Outcome Measures:
  • Serum Erythropoietin (EPO) Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow.

  • C-Reactive Protein (CRP) Level [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance.

  • Serum Hemoglobin Level [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ] [ Designated as safety issue: No ]
    Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.

  • Serum Hematocrit Level [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ] [ Designated as safety issue: No ]
    Hematocrit is the amount of red blood cells in the blood.

  • Reticulocyte Count [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ] [ Designated as safety issue: No ]
    Reticulocytes are immature red blood cells.

  • Serum Ferritin Level [ Time Frame: Baseline, Week 1 and Week 2 ] [ Designated as safety issue: No ]
    Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron.

  • Serum Iron Level [ Time Frame: Baseline, Week 1 and Week 2 ] [ Designated as safety issue: No ]
    Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.

  • Transferring Iron Binding Capacity (TIBC) [ Time Frame: Baseline, Week 1 and Week 2 ] [ Designated as safety issue: No ]
    TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.


Biospecimen Retention:   Samples Without DNA

Blood samples will be collected for hematological analysis.


Enrollment: 33
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with cancer related anemia
Participants with cancer related anemia receiving chemotherapy will be observed for response to erythropoietin treatment.
Other: No intervention
This is an observational study. Participants receiving erythropoietin (dosage and regimen will comply with Thai Food and Drug Administration approval package insert) will be observed.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736215

Locations
Thailand
Bangkok, Thailand
Chiang Mai, Thailand
Khon Kaen, Thailand
Sponsors and Collaborators
Janssen-Cilag Ltd.,Thailand
Mahidol University
Investigators
Study Director: Janssen-Cilag Ltd.,Thailand Clinical Trial Janssen-Cilag Ltd.,Thailand
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT01736215     History of Changes
Other Study ID Numbers: CR016558, EPOCAN4028
Study First Received: November 26, 2012
Results First Received: March 29, 2013
Last Updated: March 29, 2013
Health Authority: Chulalongkorn: Chulalongkorn Ethics Committee
Thailand: Ethical Committee

Keywords provided by Janssen-Cilag Ltd.,Thailand:
Anemia - cancer related
Eprex (Erythropoietin alfa)

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014