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

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ClinicalTrials.gov Identifier: NCT00039884
Recruitment Status : Unknown
Verified June 2002 by Mirhashemi, Ramin, M.D..
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Mirhashemi, Ramin, M.D.

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
Anemia Cervix Neoplasms Drug: NESP - Novel Erythropoiesis Stimulating Protein Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 64 participants
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 : September 2001
Study Completion Date : March 2003

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039884


Locations
United States, Florida
Sylvester Comprehensive Cancer Center/JMH
Miami, Florida, United States, 33136
Sponsors and Collaborators
Mirhashemi, Ramin, M.D.

ClinicalTrials.gov Identifier: NCT00039884     History of Changes
Other Study ID Numbers: 01/155A
First Posted: June 17, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2002

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

Additional relevant MeSH terms:
Anemia
Uterine Cervical Neoplasms
Hematologic Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Darbepoetin alfa
Hematinics