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

First Received on June 13, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	Mirhashemi, Ramin, M.D.
Information provided by:	Mirhashemi, Ramin, M.D.
ClinicalTrials.gov Identifier:	NCT00039884

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Cervical Cancer

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Mirhashemi, Ramin, M.D.:

Estimated Enrollment:	64
Study Start Date:	September 2001
Estimated Study Completion Date:	March 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039884

Locations

United States, Florida
Sylvester Comprehensive Cancer Center/JMH
Miami, Florida, United States, 33136

Sponsors and Collaborators

Mirhashemi, Ramin, M.D.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00039884 History of Changes
Other Study ID Numbers:	01/155A
Study First Received:	June 13, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mirhashemi, Ramin, M.D.:

Cervical cancer

Additional relevant MeSH terms:

Anemia
Neoplasms
Uterine Cervical Neoplasms
Hematologic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012