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Prediction of Response to Erythropoietin Treatment in Cancer Related Anemia Patients 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: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the predictors of response to erythropoietin treatment in cancer related anemia patients receiving chemotherapy.


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:

MedlinePlus related topics: Anemia Cancer
U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of patients achieving at least 1g/dL hemoglobin (Hb) or able to reach Hb level at 12 g/dL rise during 1-2 months of erythropoietin treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum erythropoietin (EPO) level [ Time Frame: Baseline (screening) ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) level [ Time Frame: Baseline (screening) ] [ Designated as safety issue: No ]
  • Reticulocyte count [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Hematocrit (Hct) level [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Transferring iron binding capacity(TIBC) [ Time Frame: Baseline, Week 1 and Week 2 ] [ Designated as safety issue: No ]
  • Serum hemoglobin level [ Time Frame: Baseline, Week 1, Week 2, Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Serum ferritin level [ Time Frame: Baseline, Week 1 and Week 2 ] [ Designated as safety issue: No ]

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
Patients with cancer related anemia Other: No intervention
This is an observational study. Patients receiving erythropoietin (dosage and regimen will comply with Thai Food and Drug Administration approval package insert) will be observed.

Detailed Description:

This is a single center, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), observational study (study in which the investigators/ physicians observe the patients and measure their outcomes) to identify the predictive factors that will effectively predict the response to erythropoietin treatment in anemic cancer patients who are receiving chemotherapy. Approximately 110 patients will be enrolled into this study and the entire study duration will be approximately 1 year. At baseline, Week 1, Week 2, Week 4 and Week 8, the data, from patients receiving erythropoietin treatment, for the following laboratory parameters will be collected: hemoglobin; red blood cells count; hematocrit; reticulocyte count, white blood cells and platelet count; serum iron, ferritin, and transferring iron binding capacity; serum erythropoietin level; and C-reactive protein level.

  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

Cancer related anemia patients receiving chemotherapy

Criteria

Inclusion Criteria:

  • Non-hematologic malignancy
  • Life expectancy at least 6 months based on the investigators clinical judgment
  • Receiving chemotherapy
  • Have indication and plan to receiving erythropoietin (dosage and regimen should comply with Thai FDA approval package insert)

Exclusion Criteria:

  • Patients with anemia due to other factors (ie, Iron, B12 or folate deficiencies, hemolysis, gastrointestinal bleeding, or any active bleeding)
  • Previous history of erythropoietin treatment
  • Patients who have received blood transfusion within 1 month before starting erythropoietin therapy
  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

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
Last Updated: January 8, 2013
Health Authority: Chulalongkorn: Chulalongkorn Ethics Committee
Thailand: Ethical Committee

Keywords provided by Janssen-Cilag Ltd.,Thailand:
Anemia - Cancer Related
Erythropoietin
EPO
Chemotherapy
Predictors

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

ClinicalTrials.gov processed this record on May 21, 2013