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

Anemia Clinical Trial

Official title:

Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00039884
• Other study ID #: 01/155A
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 13, 2002
• Last updated: June 23, 2005
• Start date: September 2001
• Est. completion date: March 2003

Study information

• Verified date: June 2002
• Source: Mirhashemi, Ramin, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: March 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Cervix Neoplasms
• Uterine Cervical Neoplasms

Intervention

Drug:
• NESP - Novel Erythropoiesis Stimulating Protein

Locations

Country	Name	City	State
United States	Sylvester Comprehensive Cancer Center/JMH	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mirhashemi, Ramin, M.D.

Country where clinical trial is conducted

United States,