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


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Anemia

General anemia


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

This study is currently recruiting patients.

Sponsored by: Amgen
Information provided by: Mirhashemi, Ramin, M.D.

Purpose

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.

Condition Treatment or Intervention Phase
Anemia
Cervix Neoplasms
 Drug: NESP - Novel Erythropoiesis Stimulating Protein
Phase II

MedlinePlus related topics:  Anemia;   Cervical Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  64

Study start: September 2001;  Expected completion: March 2003

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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

Location and Contact Information


Florida
      Sylvester Comprehensive Cancer Center/JMH, Miami,  Florida,  33136,  United States; Recruiting
Jane Arboleda, R.N.  305-243-2233    jarboleda@med.miami.edu 
Ramin Mirhashemi, M.D.,  Principal Investigator

More Information

Study ID Numbers:  01/155A
Record last reviewed:  June 2002
Last Updated:  October 13, 2004
Record first received:  June 13, 2002
ClinicalTrials.gov Identifier:  NCT00039884
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: May 11, 2006
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