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

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

This study is ongoing, but not recruiting participants.

Sponsored by:	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

MedlinePlus related topics:

Anemia Cancer Cervical Cancer

ChemIDplus related topics:

Darbepoetin alfa

U.S. FDA Resources

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.

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

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

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

Cervical cancer

Study placed in the following topic categories:

Genital Diseases, Female

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Hematologic Diseases

Darbepoetin alfa

Genital Neoplasms, Female

Anemia

Uterine Diseases

Uterine Neoplasms

Urogenital Neoplasms

Carcinoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Hematinics

Therapeutic Uses

Hematologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008