Overview

This trial is active, not recruiting.

Conditions anemia, cervix neoplasms
Treatment nesp - novel erythropoiesis stimulating protein
Phase phase 2
Sponsor Mirhashemi, Ramin, M.D.
Start date September 2001
End date March 2003
Trial size 64 participants
Trial identifier NCT00039884, 01/155A

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind
Primary purpose treatment

Eligibility Criteria

Female participants at least 18 years old.

- 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

Additional Information

Official title Phase II Study of NESP (Novel Erythropoiesis Stimulating Protein) During Concurrent Chemo-Radiation for the Treatment of Cervical Carcinoma.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Mirhashemi, Ramin, M.D..