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

Sponsor
Mirhashemi, Ramin, M.D. (Other)
Overall Status
Unknown status
CT.gov ID
NCT00039884
Collaborator
(none)
64
Enrollment
1
Location
17.9
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: NESP - Novel Erythropoiesis Stimulating Protein
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.
Study Start Date :
Sep 1, 2001
Study Completion Date :
Mar 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes

    • 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

    Locations

    Site City State Country Postal Code
    1 Sylvester Comprehensive Cancer Center/JMH Miami Florida United States 33136

    Sponsors and Collaborators

    • Mirhashemi, Ramin, M.D.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00039884
    Other Study ID Numbers:
    • 01/155A
    First Posted:
    Jun 17, 2002
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Jun 1, 2002
    Keywords provided by , ,
    Cervical cancer
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Anemia
    Darbepoetin alfa

    Study Results

    No Results Posted as of Jun 24, 2005