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

• Conditions: Anemia in cancer patients receiving chemotherapy; MedDRA version: 9.1Level: LLTClassification code 10039812Term: Secondary anaemia

• Registration Number: EUCTR2006-000914-19-IT
• Lead Sponsor: JANSSEN-CILAG INTERNATIONAL NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified