Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?

Mirhashemi, Ramin, M.D.

Status and phase: Unknown; Phase 2

Conditions: Anemia; Cervix Neoplasms

Treatments: Drug: NESP - Novel Erythropoiesis Stimulating Protein

Study type: Interventional

Identifiers

NCT00039884

01/155A

Details and patient eligibility

About

This 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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind