A Study of Recombinant Human Erythropoietin Beta (NeoRecormon) in Anemic Cancer Participants Treated With Chemotherapy

Study Overview
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Brief Summary
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This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.

Official Title
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Pilot Study for Evaluating the Efficacy and Tolerability of Induction Therapy With Recombinant Human Erythropoietin Beta (rHuEPO) NeoRecormon® - at High Dose in Anemic Cancer Patients Treated With Chemotherapy

Conditions
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Anemia

Intervention / Treatment
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* Drug: r-HuEPO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological confirmed cancer Participants who are treated with at least first line chemotherapy Hemoglobin less than (<) 11 grams per deciliter (g/dL) Participants able to receive iron supplement, if necessary Exclusion Criteria: History of hypersensitivity to active or inactive excipients of r-HuEPO Insufficient controllable hypertension Thalassemic syndromes Anemia caused by hematic loss Women who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: r-HuEPO<br>Anemic cancer participants will receive r-HuEPO for 4 weeks. | Drug: r-HuEPO<br>* All participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.<br>* Other names: NeoRecormon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Response to Treatment | Response to treatment was defined as an increase of greater than (>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Response | Time to response was defined as the time between the start of treatment and the increase in hemoglobin level >1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method. | Baseline up to Week 4 | 
| Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment | Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes >40000 per microliter or >25% increase in soluble transferrin receptor or >0.5 g/dL increase in hemoglobin level. | Week 2 | 
| Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment | No Response to treatment after 4 weeks was defined as meeting any of the following criteria: <1 g/dL increase in hemoglobin level or hemoglobin level <8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of >1 g/dL but required transfusion then the participant is considered as Non- Responder. | Week 4 | 
| Percentage of Participants Who Required Transfusion |  | Baseline, Week 2, Week 4 | 
| Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4 | FACT-An comprises of 4 subscales of 27-item (FACT-General scale [FACT-G]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188. | Baseline, Week 4 |