Anemia in patients with cancer
Conditions
Interventions
Trade Name: NeoRecormon
30 000 IU solution for injection in pre-filled syringe
Product Name: NeoRecormon
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Epoetin beta
CAS Number: 12231
Sponsors
Roche AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients (age =18 years) with anemia and cancer of e.g. lung, breast, colorectum, prostate or cancer of gynecological origin; as well as patients with anemia and low grade lymphoma, B-chronic lymphatic leukemia or multiple myeloma. - Histologically and/or cytologically proven diagnosis - Transfusion requirement =2 units packed RBCs during the last 3 months prior to study treatment - Hb 4 months - WHO performance status grade 0-2 - Written informed consent according to Helsinki declaration Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Relevant acute or chronic bleeding within 3 months prior to study treatment - Ongoing chemotherapy where cessation is planned to occur in the next eight weeks - Nonpalliative radiation therapy with curative intention as sole treatment - Therapy-resistant hypertension, diastolic BP >100 mmHg - Absolute iron deficiency (s-ferritin 1000µg/L - Thrombocytopenia: platelet count 500x109/L - S-Creatinine >175µmol/L - B12 deficiency (S-cobalamine < lower normal limit) - Folate deficiency (S-folate < lower normal limit) - Autoimmune hemolysis - Uncontrolled cardiac arrhythmias or heart failure - Angina pectoris when Hb <100g/L - Known allergy to any of the study medications - Pregnancy or lactation period - Unreliable contraception - Administration of any investigational drug to patient within 30 days preceding the first dose of the study drug or during trial. - Epoetin treatment in the last 3 months - Myelodysplastic syndrome (MDS) or head /neck cancer - Prior diagnosis of primary red cell disorders which cause anemia (i.e., hemoglobinopathy, pure red cell aplasia [PRCA])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are to determine efficacy of each of the three treatments, associated resource utilization, as well as the safety of each of the three treatments. ;Main Objective: To investigate the effects of three different therapeutic alternatives to treat anemia in patients with cancer on efficacy, quality of life, and resource utilization. The primary objective is to determine the percent of subjects within each treatment arm maintained on a Hb =110g/L in at least 4 weekly Hb measurements during the 12-week study period (primary endpoint) in response to any one of the three treatments. The primary hypothesis is that at the end of the12-week treatment period, 85% of subjects in the active transfusion (A) arm will have reached the primary endpoint, 60% in the epoetin beta (E) arm, and 20% in the conventional transfusion (C) arm. ;Primary end point(s): Percent of subjects within each arm maintained on a Hb =110g/L in at least 5 weekly Hb measurements during the study period. | — |
Countries
Sweden
Outcome results
None listed