A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia. - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-000914-19-IT
• Date of registration: 13/03/2007
• Prospective Registration: No
• Primary sponsor: JANSSEN-CILAG INTERNATIONAL NV
• Public title: A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia. - ND
• Scientific title: A randomized, open-label, multicenter study evaluating thrombovascular events in subjects with cancer receiving chemotherapy and administered epoetin alfa once or three times a week for the treatment of anemia. - ND
• Date of first enrolment: 30/10/2006
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-000914-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

France, Germany, Greece, Italy, United Kingdom

Key inclusion & exclusion 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 1.5 times the upper limit of normal ULN ; aspartate aminotransferase AST , alanine aminotransferase ALT , alkaline phosphatase 3 times the ULN TSAT e20 Female subjects must be postmenopausal for at least 1 year , surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization before randomization; have a negative serum beta-human chorionic gonadotropin -hCG pregnancy test within 2 weeks before randomization; and a negative urine pregnancy test at randomization. Subjects or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
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:
-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 and myocardial infarction with or without ST elevation -Onset of seizures within 3 months before randomization or poorly controlled seizures -Brain tumor or brain metastasis from another malignancy -Evidence of heart disease classified as Class 3 to 4 cardiac disease by the New York Heart Association NYHA Classification of Cardiac Disease Attachment 4 -Significant arrhythmias -Uncontrolled hypertension systolic 180 mmHg, diastolic 100 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 325 mg/d or other anti-platelet drugs e.g., clopidogrel 75 mg/d or ticlopidine 250 mg b.i.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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Anemia in cancer patients receiving chemotherapy
MedDRA version: 9.1 Level: LLT Classification code 10039812 Term: Secondary anaemia

Intervention(s)

Trade Name: EPREX*IV FL 4000UI 1ML

Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erythropoietin
CAS Number: 113427-24-0
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 4000-

Trade Name: EPREX*IV FL 10000UI 1ML

Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erythropoietin
CAS Number: 113427-24-0
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 10000-

Trade Name: EPREX*1FL 40000UI/ML 1ML

Pharmaceutical Form: Solution for injection
INN or Proposed INN: Erythropoietin
CAS Number: 113427-24-0
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 40000-

Primary Outcome(s)

Secondary Objective: Secondary efficacy objectives include assessment of change in Hb, proportion of responders to epoetin alfa, and the use of red blood cell RBC transfusions. Secondary safety objectives include rate of rise in Hb; time to first clinically relevant and objectively confirmed TVE; the proportion of subjects with at least one TVE during the study and the total number of TVEs, whether clinically relevant and objectively confirmed or not; and time to death. Overall safety including adverse events, clinical laboratory values, and mortality will also be assessed.

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 ID(s)

2006-000914-19-DE

EPO-ANE-4008