A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia (NCT01394991) | Clinical Trial Compass
CompletedPhase 4
A Safety Study of Epoetin Alfa in Patients With Cancer Who Have Chemotherapy-Related Anemia
504 participantsStarted 2006-01
Plain-language summary
The purpose of the study is to evaluate the safety of epoetin alfa in patients with cancer who have chemotherapy-related anemia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any nonmyeloid tumor confirmed by cytology and/or histology
* Day 1 baseline hemoglobin (Hb) level \<=11 g/dL
* Expected to receive at least 12 weeks of chemotherapy after enrollment into the study
* Eastern Cooperative Oncology Group (ECOG) performance status \<= 2
Exclusion Criteria:
* History of active second cancer except for adequately treated skin cancer and in situ (pre-invasive) cervical cancer
* History of deep venous thrombosis (DVT) (blood clots in the veins of the thighs or legs) or pulmonary embolism (PE) (blood clot in the lungs) 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
* History of cardiovascular accident (CVA), transient ischemic attack (TIA) (stroke), acute coronary syndrome (ACS) (a condition indicating damage to the heart), or other arterial thrombosis (blood clots) within 6 months before study entry
* Onset of seizures within 3 months before randomization or poorly controlled seizures
* Brain tumor or brain metastasis from another malignancy or cardiac disease that is markedly or completely limiting, uncontrolled hypertension (high blood pressure), or anemia (a lack of red blood cells in the blood) for reasons other than cancer or chemotherapy
* Specifically excluded concomitant medications or therapies including prophylactic anticoagulation the…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16
Timeframe: from randomization through Week 16
Trial details
NCT IDNCT01394991
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.