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.
|
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.
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
Ramin Mirhashemi, M.D., Principal Investigator
More Information
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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