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
18 Years
N/A
Open (Enrolling)
Female
Anemia, Cervix Neoplasms
Female
Anemia, Cervix Neoplasms
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/JMH | Miami, Florida 33136 |
