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Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Anemia, Cervix Neoplasms

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Trial Information

Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

01/155A

NCT ID:

NCT00039884

Start Date:

September 2001

Completion Date:

March 2003

Related Keywords:

  • Anemia
  • Cervix Neoplasms
  • Cervical cancer
  • Anemia
  • Neoplasms
  • Uterine Cervical Neoplasms

Name

Location

Sylvester Comprehensive Cancer Center/JMHMiami, Florida  33136