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

This study is ongoing, but not recruiting participants.

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

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 Radiation Therapy

Drug Information available for: 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

No publications provided

Study ID Numbers:	01/155A
Study First Received:	June 13, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00039884 History of Changes
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
Hematinics
Hematologic Diseases
Darbepoetin alfa

Genital Neoplasms, Female
Anemia
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms
Carcinoma

Additional relevant MeSH terms:

Hematologic Diseases
Hematinics
Hematologic Agents
Anemia
Genital Neoplasms, Female
Darbepoetin alfa
Uterine Diseases
Urogenital Neoplasms

Pharmacologic Actions
Uterine Cervical Neoplasms
Genital Diseases, Female
Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Therapeutic Uses
Uterine Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009