Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2002 by Mirhashemi, Ramin, M.D..
Recruitment status was Active, not recruiting
Information provided by:
Mirhashemi, Ramin, M.D.
First received: June 13, 2002
Last updated: June 23, 2005
Last verified: June 2002
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.
Drug: NESP - Novel Erythropoiesis Stimulating Protein
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
||Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039884
|Sylvester Comprehensive Cancer Center/JMH
|Miami, Florida, United States, 33136 |
Mirhashemi, Ramin, M.D.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 13, 2002
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by Mirhashemi, Ramin, M.D.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Uterine Cervical Diseases