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
Sponsor:
Information provided by:
Mirhashemi, Ramin, M.D.
ClinicalTrials.gov Identifier:
NCT00039884
First received: June 13, 2002
Last updated: June 23, 2005
Last verified: June 2002
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014