A Study of the Effectiveness and Safety of Treatment With Epoetin Alfa on Hemoglobin Levels, Red Blood Cell Transfusions, and Quality of Life in Patients With Cancer Receiving Platinum-containing Chemotherapy

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effectiveness of early treatment of anemia with epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard anemia care on the need for blood transfusions, tumor response, anemia and quality of life in patients with cancer receiving platinum-containing chemotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag B.V.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients having a confirmed diagnosis of cancer and are planned to receive platinum chemotherapy with a minimum of 8 weeks on study and a maximum of 6 or 12 cycles

• Eastern Cooperative Oncology Group (a scale used by researchers to represent the level of activity that a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 3 (capable of only limited self-care, confined to bed or chair >50% of waking hours)

• life expectancy of >=5 months

• have a hemoglobin value of <=7.5 grams per deciliter at any time during or prior to chemotherapy

Exclusion Criteria:

• Patients having clinically significant disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurological, gastrointestinal, or genitourinary systems that is not due to cancer or chemotherapy (this disease/dysfunction is only an exclusion criterion if it causes an expected early withdrawal from the study)

• uncontrolled high blood pressure

• history of seizures

• untreated iron, folate, or vitamin B12 deficiency

• received androgen (e.g., testosterone) therapy within 2 months of study entry, had a major illness within 7 days of study entry, or a major infection within 1 month of study entry