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Epoetin Alfa

The purpose of this registry is to record information of routine treatment of anemia in cancer patients in Germany. An overview of the current treatment of anemia in German outpatient centers and hospitals will be provided. Primary outcome parameters, e.g. improvement in hemoglobin levels and changes in QoL, as well as patient characteristics of different treatments will be analyzed.

Clinical Tumor Anemia Registry (TAR)

Clinical Registry Describing Treatment Reality of Patients With Cancer-(Therapy)-Induced Anemia

Overview on the current routine treatment of anemia in cancer patients in Germany

Effectiveness of different antianemic treatments is investigated by measuring increase of hemoglobin levels and QoL (FACT-An and FACT-GP).

Baseline in hemoglobin (before treatment) is compared with hemoglobin levels after treatment. Each patient is followed for a maximum of 12 weeks to obtain data about the course of the treatment.

ASORS (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie, Rehabilitation und Sozialmedizin der Deutschen Krebsgesellschaft)

iOMEDICO AG

epoetin alfa

Janssen-Cilag B.V. Clinical Trial

The purpose of this study is to evaluate the effect of early treatment with epoetin alfa in addition to best standard of care on hemoglobin levels and the need for red blood cell transfusions in cancer patients receiving chemotherapy as compared to patients receiving standard epoetin alfa treatment and best standard of care.

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the tiredness associated with anemia. Previous studies with epoetin alfa have suggested that early intervention with epoetin alfa results in higher hemoglobin levels and lower incidence of red blood cell transfusions than are achieved with delayed intervention. This is a randomized, open-label, explorative, sequential study that evaluates the effects of early treatment with epoetin alfa to determine its impact on hemoglobin values and the need for red blood cell transfusions as well as the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer. During their current course of chemotherapy, patients will receive either early treatment with epoetin alfa or standard treatment with epoetin alfa (epoetin alfa administered when hemoglobin is \<=10 g/dL), in addition to best standard care. Best standard care during chemotherapy may include red blood cell transfusions, white cell growth factors, folic acid, and iron supplementation, as needed. Effectiveness will be determined by the number of patients who receive an allogenic blood transfusion during the study and the change in hemoglobin at 3 or 4 weeks, 8 or 9 weeks, and 12 weeks, and at the end of the treatment period. Safety evaluations (incidence of adverse events, abnormal clinical laboratory tests, and vital signs) will be performed throughout the study. The study hypothesis is that cancer patients receiving chemotherapy who receive early treatment with epoetin alfa will have higher hemoglobin levels and fewer red blood cell transfusions than cancer patients receiving chemotherapy who receive standard treatment with epoetin alfa. This study will be conducted in the Netherlands and will only enroll European patients and will be generally well-tolerated. Epoetin alfa injections (40,000 units) under skin once a week either within 7 days after start of first chemotherapy cycle or from day hemoglobin is \<=10 g/dL. Patients will receive epoetin alfa during the current course of chemotherapy or up to 24 weeks. Dose may be adjusted.

A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy

Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy

Janssen-Cilag B.V.

Neoplasms

Heart and Blood Diseases

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing the transfusion requirements in anemic patients with multiple myeloma, and to investigate the quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Cancer patients often experience anemia due to the disease itself, chemotherapy or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This study is a 12-week randomized, double-blind, placebo-controlled, multicenter study (with an open-label extension) to assess the effectiveness of treatment with epoetin alfa in reducing the need for red cell transfusion by improving anemia in patients with multiple myeloma whose hemoglobin is less than 11 grams per deciliter. There will be 4 groups of patients in the study. Patients will first be placed into 2 groups according to whether or not they received at least 1 blood transfusion within the previous 3 months. Within each of these 2 groups, patients will then be randomly assigned to receive either epoetin alfa or placebo for 12 weeks. Dosing is initiated at 150 units per kilogram (U/kg) injected under the skin 3 times weekly for 4 weeks, then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. All patients who complete the 12-week double-blind period will be eligible to continue receiving epoetin alfa for an additional 12 weeks in an open-label extension of the study. The primary measures of effectiveness will be determined by the number of units of blood transfused, the proportion of patients requiring transfusion, and the number of units transfused relative to whether or not they received transfusions before the study. Additional effectiveness measures include the number of patients whose hemoglobin level reach at least 12 grams per deciliter (anemia considered "corrected") or who have an increase in hemoglobin of at least 2 grams per deciliter, and the change in the percentage of red blood cells and number of developing red blood cells in the blood. Changes in quality-of-life (Nottingham and visual analog scale) and performance scores will also be measured. Safety evaluations (incidence of adverse events, laboratory tests, and vital signs) and changes in underlying multiple myeloma will be assessed. The hypothesis of the study is that epoetin alfa will be superior to placebo in reducing the need for transfusions and improving anemia and quality of life. Double-blind: Epoetin alfa 150 units per kilogram (U/kg) injected under the skin 3 times weekly for 4 weeks; then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. Open-label: dose to maintain target hemoglobin range.

The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma

A Placebo-Controlled Study on the Effect of r-huEPO in Patients With Multiple Myeloma Followed by an Open-Label Extension

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Epoetin alfa

The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer on non-platinum chemotherapy, and to investigate quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This is a randomized, double-blind, placebo-controlled, multicenter study to assess the effect of treatment with epoetin alfa in reducing or preventing anemia and transfusions in patients receiving non-platinum chemotherapy for non-myeloid cancers. The study also aims to determine whether changes in erythropoietin and hemoglobin levels after 2 weeks, serum ferritin (iron) levels after 2 weeks and changes in hemoglobin and developing red blood cells after either 2 or 4 weeks predict responsiveness to epoetin alfa. There will be 2 treatment groups: one group will receive subcutaneous epoetin alfa injections 3 times per week (starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per kilogram) and the other group will receive an equal volume of matching subcutaneous placebo. Treatment is to continue for 12 to 24 weeks (3 to 6 chemotherapy cycles), plus 4 weeks post-chemotherapy. Patients in the study will be observed a year after the study ends for survival data. The primary measure of effectiveness will be determined by the number of patients who are transfused, depending on primary tumor type (solid or blood) and level of hemoglobin (above or below 10.5 grams per deciliter). Additional measures of effectiveness include the change in hemoglobin, hematocrit, and developing red blood cells from the start of the study until study completion, and the change in quality of life. Safety evaluations (incidence and severity of adverse events, laboratory tests, vital signs and physical examinations) will be performed throughout the study. The hypothesis of the study is that epoetin alfa will be superior to placebo in reducing the need for transfusions and in improving anemia and quality of life. 150 units per kilogram of epoetin alfa (or placebo) 3 times weekly subcutaneously for 4 weeks, then continuing this dose or 300 units per kilogram, depending on developing red blood cell counts and/or hemoglobin. Study duration is 12 to 24 weeks (3 to 6 cycles) plus 4 weeks post-chemotherapy.

Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy

Double-Blind, Placebo-Controlled Study to Assess the Effect of Early Intervention and/or Treatment With Epoetin Alfa on Anemia in Cancer Patients Receiving Non-Platinum-Containing Chemotherapy

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphoma

Carcinoma, Small Cell

Esophageal Neoplasms

Lung Neoplasms

Small Cell Lung Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Neoplasms, Glandular and Epithelial

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Lymphosarcoma

Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve quality of life and help patients live longer. This study is a 12-week, double-blind, placebo-controlled multicenter study to compare the ability of epoetin alfa and placebo in reducing or preventing anemia and transfusions, and to investigate quality-of-life benefits associated with the use of epoetin alfa in patients receiving chemotherapy for selected cancers. During the double-blind period there will be two groups of patients: one group receiving epoetin injections under the skin 3 times per week (starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per kilogram) and other group receiving injections under the skin of a placebo of matching appearance and volume. If hemoglobin rises above 140 grams per liter (women) or 150 grams per liter (men), the dose will be adjusted to keep hemoglobin within a target range. A 12-week open-label extension of the study will be available to all patients completing the 12-week comparison period. The primary measure of effectiveness is determined by the proportion of patients with no transfusions after the first month. Additional measures of effectiveness include: the proportion of responders, the change of hemoglobin unrelated to transfusion, cumulative transfusion rate and proportion of patients transfused during the double-blind phase (excluding the first month), as well as the mean change over the study period in scores for energy, activity and overall quality of life. The results will be analyzed separately for non-platinum-containing chemotherapy and for different tumor types. Safety evaluations include assessments of the incidence and severity of adverse events, clinical laboratory tests, vital sign measurements, and physical examinations. The hypothesis of the study is that epoetin alfa is superior to placebo in improving anemia, reducing the number of transfusions, and improving quality of life. Epoetin alfa 150 units (U) per kilogram (kg) or placebo, injected under the skin 3 times weekly for 4 weeks; then either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the remaining 8 weeks. Open-label (12 weeks): dose to maintain target hemoglobin range.

The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy

A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy

The purpose of this study is to compare the effectiveness of early treatment of anemia with epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard anemia care on the need for blood transfusions, tumor response, anemia and quality of life in patients with cancer receiving platinum-containing chemotherapy.

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the tiredness associated with anemia. Previous studies with epoetin alfa have suggested that epoetin alfa increases hemoglobin and reduces the incidence of red blood cell transfusions and that achieving a higher hemoglobin level may improve quality of life. This is a randomized, open-label, multicenter study that evaluates the effects of early treatment with epoetin alfa compared with standard anemia care alone to determine its impact on the need for blood transfusions, tumor response, anemia and quality of life, as well as on the safety of epoetin alfa when used in the prevention of anemia during chemotherapy in adult patients with cancer. Patients will receive epoetin alfa injections (10,000 units) under the skin 3 times a week until 4 weeks after the last day of the last chemotherapy cycle, in addition to best standard care, or best standard care alone. Best standard care during chemotherapy may include red blood cell transfusions, white cell growth factors, and iron supplementation, as needed. The dose of epoetin alfa may be adjusted up (to 20,000 units) or down (to 75% of the last dose) based on hemoglobin level.

The primary measure of effectiveness will be determined by the number of patients who receive an allogenic red blood cell transfusion during the study and during each chemotherapy cycle. Additional measures of effectiveness include: the average number of units transfused during each cycle, change in quality of life (feeling of well-being, as assessed by responses to 3 different patient questionnaires), change in hemoglobin level, relationship between change in hemoglobin and quality of life, tumor response, and the number of patients surviving up to 12 months after the end of treatment. Safety evaluations (incidence of adverse events, clinical laboratory tests, vital signs, and physical examinations) will be performed throughout the study. The study hypothesis is that treatment with epoetin alfa will reduce the need for red blood cell transfusions, increase hemoglobin levels, improve quality of life, and result in a positive tumor response in patients with cancer who are receiving chemotherapy. This study will be conducted in the Netherlands and will only enroll European patients. Patients will receive epoetin alfa injections (10,000 units) under the skin 3 times a week until 4 weeks after the last day of the last chemotherapy cycle, or best standard care. Dose may be adjusted up (to 20,000 units) or down (to 75% of the last dose) based on hemoglobin level.

A Study of the Effectiveness and Safety of Treatment With Epoetin Alfa on Hemoglobin Levels, Red Blood Cell Transfusions, and Quality of Life in Patients With Cancer Receiving Platinum-containing Chemotherapy

An Open-label, Randomized Study to Evaluate the Effect of Early Treatment of Anemia With Epoetin Alfa on Hemoglobin, the Incidence of Blood Transfusions and Quality of Life in Patients Receiving Platinum-containing Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Tumor Anemia Registry (TAR)	NCT01795690	Anemia		18 Years -	iOMEDICO AG
A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy	NCT00216541	Anemia Neoplasms	epoetin alfa	18 Years -	Janssen-Cilag B.V.
The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma	NCT00270101	Anemia Multiple Myelom...	epoetin alfa	40 Years - 80 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy	NCT00270127	Anemia Cancer Neoplasm	Epoetin alfa	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Study of the Safety and Effectiveness of Epoetin Alfa on Hemoglobin Levels and Blood Transfusions in Cancer Patients Receiving Chemotherapy	NCT00216541	Anemia Neoplasms	epoetin alfa	18 Years -	Janssen-Cilag B.V.
The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma	NCT00270101	Anemia Multiple Myelom...	epoetin alfa	40 Years - 80 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy	NCT00270166	Anemia Multiple Myelom... Lymphoma Breast Cancer Ovarian Cancer Carcinoma, Smal... Esophagus Cance... Prostate Cancer Neoplasm	epoetin alfa	18 Years - 80 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy	NCT00270127	Anemia Cancer Neoplasm	Epoetin alfa	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The Effect of Epoetin Alfa on the Anemia of Patients With Multiple Myeloma	NCT00270101	Anemia Multiple Myelom...	epoetin alfa	40 Years - 80 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Study of the Effectiveness and Safety of Treatment With Epoetin Alfa on Hemoglobin Levels, Red Blood Cell Transfusions, and Quality of Life in Patients With Cancer Receiving Platinum-containing Chemotherapy	NCT00283465	Anemia Neoplasm	Epoetin alfa	18 Years -	Janssen-Cilag B.V.
Clinical Tumor Anemia Registry (TAR)	NCT01795690	Anemia		18 Years -	iOMEDICO AG

Spots Global Cancer Trial Database for epoetin

Every month we try and update this database with for epoetin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for epoetin

Every month we try and update this database with for epoetin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for epoetin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.