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

Tracking Information
First Received Date ^ICMJE	June 13, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00039884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
Official Title ^ICMJE	Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Anemia Cervix Neoplasms
Intervention ^ICMJE	Drug: NESP - Novel Erythropoiesis Stimulating Protein
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	64
Completion Date	March 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00039884
Responsible Party
Study ID Numbers ^ICMJE	01/155A
Study Sponsor ^ICMJE	Mirhashemi, Ramin, M.D.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Mirhashemi, Ramin, M.D.
Verification Date	June 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP