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

NCT01736215 | Terminated Results

• 2 other identifiers: CR016558EPOCAN4028
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Anemia - Cancer Related

Keywords

Anemia - cancer related; Eprex (Erythropoietin alfa)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Response to Erythropoietin Treatment

  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.

  8 weeks

Secondary Outcomes (8)

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

  Baseline

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

  Baseline

• Serum Hemoglobin Level

  Baseline, Week 1, Week 2, Week 4 and Week 8

• Serum Hematocrit Level

  Baseline, Week 1, Week 2, Week 4 and Week 8

• Reticulocyte Count

  Baseline, Week 1, Week 2, Week 4 and Week 8

Study Arms (1)

Participants with cancer related anemia

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

Drug: Erythropoietin: Observational study

Interventions

Erythropoietin: Observational study DRUG

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.

Participants with cancer related anemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.,Thailand: lead
• Mahidol University: collaborator

Study Sites (3)

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

Unknown Facility

Khon Kaen, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for hematological analysis.

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Janssen Cilag Thailand

+6627927232

Study Officials

• Janssen-Cilag Ltd.,Thailand Clinical Trial

  Janssen-Cilag Ltd.,Thailand

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: November 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 29, 2014
• Results First Posted: May 30, 2013

Record last verified: 2014-03

Locations

TH (3)