Anemia in cancer patients receiving chemotherapy MedDRA Version 5.1 : list of preferred terma used in the process of defining thrombotic vascular events, see investigators brochure epoetin alpha.
Conditions
Interventions
Trade Name: EPREX 10,000 IU/ml
solution for injection
Product Name: EPOETIN ALFA/ 10.000 IU/ml
Product Code: EPO
Pharmaceutical Form: Solution for injection
Trade Name: EPREX 40,000 IU/ml
solution
Sponsors
Janssen-Cilag International N.V., Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: " Men or women, 18 years of age or older " Any histologically confirmed nonmyeloid tumor at initial diagnosis " Day 1 baseline Hb d11 g/dL " Expected to receive at least 12 weeks of chemotherapy after enrollment into the study. For subjects receiving cyclic chemotherapy, randomization must be on the first day of a chemotherapy cycle. For subjects receiving non-cyclic chemotherapy, randomization may occur at any time during the chemotherapy. " ECOG performance status d2 (Attachment 3) " Life expectancy of >6 months, based on the clinical judgment of the investigator " Normal neutrophil count (>1.5 x 109/L) at start of initial chemotherapy " Normal platelet count (>100 x 109/L) at start of initial chemotherapy " Serum creatinine and bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: " History of active second cancer except for adequately treated skin cancer and in situ cervical cancer " History of DVT or PE within 12 months before study entry or at any time if the event is related to the current cancer, which is defined as diagnosis of the cancer within 3 months of a DVT/PE episode or a DVT/PE following the cancer diagnosis/treatment. Prior superficial thrombophlebitis is not an exclusion criterion. " History of CVA, TIA, ACS, or other arterial thrombosis within 6 months before study entry. ACS includes unstable angina, QwMI, and NQMI " Onset of seizures within 3 months before randomization or poorly controlled seizures " Brain tumor or brain metastasis from another malignancy " Evidence of ischemic heart disease, New York Heart Association (NYHA) Class 3 to 4 cardiac disease (Attachment 4) or significant arrhythmias " Uncontrolled hypertension (systolic = 140 mmHg, diastolic = 90 mmHg) while receiving antihypertensive therapy or not on therapy " Anemia secondary to vitamin B12, folic acid, or iron deficiency " Anemia known to be secondary to gastrointestinal bleed, hemolysis (acquired or hereditary, e.g., sickle cell syndrome, thalassemia syndrome), PRCA, or primary myelodysplastic syndrome " Presence of other comorbid conditions or illnesses of the cardiovascular, respiratory, renal, or other body systems that would preclude administration of planned chemotherapy " Previous therapy with any marketed epoetin product within 2 months before randomization, lack of response to prior therapy with any epoetin product, or use of any investigational epoetin product at any time " Major surgery within 4 weeks before randomization or any preplanned surgery during the study " Current treatment with therapeutic or prophylactic anticoagulants. The only exceptions are low dose aspirin (d325 mg/d) in subjects with known cardiovascular disease or low dose anticoagulants to maintain patency of intravenous lines " Planned myeloablative chemotherapy with stem cell rescue or bone marrow transplant " Have received an experimental drug or used an experimental medical device within 3 months before the planned start of treatment. " Is pregnant or breast-feeding " Known hypersensitivity to epoetin alfa, or mammalian-cell derived products or formulation excipients " Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the proportion of subjects with at least 1 clinically relevant and objectively confirmed TVE from randomization through Week 16.;Main Objective: The primary objective is to compare the safety with respect to the incidence of clinically relevant and objectively confirmed TVEs in 2 dosing regimens of epoetin alfa when used following guidelines for baseline Hb (<=11 g/dL) and target Hb ( 12 g/dL) to treat anemia in subjects with nonmyeloid malignancies who are receiving chemotherapy.;Secondary Objective: Seconday efficacy objectives include assessment of change in Hb, proportion of responders to epoetin alfa, and red blood cell (RBC) transfusion. Secondary safety objectives include rate of rise in Hb, time to clinically relevant and objectively confirmed TVE, and time to death. Overall safey including adverse events and clinical laboratory values will also be assessed. | — |
Countries
France, Germany, Greece, Italy, United Kingdom
Outcome results
None listed