Anemia Study in Patients with Non-Small Cell Lung Cancer

Principal Investigator: Addison Tolentino, MD

Sub-Investigators: David Elson, MD; Mark Huber, MD; Michael Robinson, MD

Study Coordinator: Marilyn Plueger, CRC

Study Description: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-Term Safety and Efficacy of Darbepoetin Alfa Administered at 500 μg Once Every 3 Weeks (Q3W) in Anemic Subjects with Advanced Stage Non-Small Cell Lung Cancer Receiving Multi-Cycle Chemotherapy

Overview: Anemia is a condition in which the number of red blood cells in the body is abnormally low. Red blood cells are important because they contain hemoglobin which carries oxygen throughout the body to tissues and organs. Chemotherapy used to treat cancer patients often causes anemia.

The purpose of this study is to determine the safety of an investigational medication, including effects on patient survival and cancer progression, as well as the need for blood transfusions.

Inclusion Criteria:

• Age 18 and older
• Metastatic (stage IV) or advanced stage IIIB with malignant pleural effusion non-small cell lung cancer (NSCLC)
• Receiving or about to receive first line cyclic chemotherapy for NSCLC and expected to receive at least 2 additional cycles of cyclic chemotherapy
• Chemotherapy-induced anemia

Exclusion Criteria:

• Known primary benign or malignant blood disorder which can cause anemia
• Uncontrolled high blood pressure
• Uncontrolled angina, uncontrolled heart failure or uncontrolled cardiac arrhythmia
• Women who are pregnant, breastfeeding or planning to become pregnant

Contact: Marilyn Plueger

Phone:  (605) 322-3096

Email:   marilyn.plueger@avera.org