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NCT00039884 Clinical Trial

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
Secondary ID
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
Est. primary completion date
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

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, 

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