Title
Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.
Phase
Phase 2Lead Sponsor
Mirhashemi, Ramin, M.D.Study Type
InterventionalStatus
Unknown statusIndication/Condition
Anemia Cervix NeoplasmsIntervention/Treatment
darbepoetin alfa ...Study Participants
64This is a clinical trial (a type of research study) designed to describe the efficacy (effectiveness) and toxicity (safety) of a new medical treatment, NESP (Novel Erythropoiesis Stimulating Protein). This study will be offered to patients with cervical cancer undergoing a combination of chemotherapy and radiation. This treatment may lower your red blood cells. The use of NESP may stimulate the body to produce more red blood cells. Our hypothesis is that higher red blood cells will be beneficial to the patient during treatment for cervical cancer.
Consent form completed and signed Hemoglobin between 9-13 g/dL Life expectancy of at least 4 months Karnofsky Performance Status =/> 70 No evidence of hemolysis, GI bleeding, or bleeding due to recent surgery Adequate renal and liver function