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.
- Conditions
- Anemia in cancer patients receiving chemotherapy
- Registration Number
- EUCTR2006-000914-19-GR
- Lead Sponsor
- Johnson & Johnson Pharmaceutical Research & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
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 (²-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
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 >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 (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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;Primary end point(s): The primary endpoint is the proportion of subjects with at least 1 clinically<br>relevant and objectively confirmed TVE from randomization through<br>Week 16.
- Secondary Outcome Measures
Name Time Method