Back to resultsWill Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
Primary Purpose
Anemia, Cervix Neoplasms
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NESP - Novel Erythropoiesis Stimulating Protein
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Cervical cancer
Eligibility 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
Sites / Locations
- Sylvester Comprehensive Cancer Center/JMH
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00039884
Brief Title
Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
Official Title
Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2002
Overall Recruitment Status
Unknown status
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mirhashemi, Ramin, M.D.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Cervix Neoplasms
Keywords
Cervical cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NESP - Novel Erythropoiesis Stimulating Protein
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Sylvester Comprehensive Cancer Center/JMH
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
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Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
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