NCT00039884

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 2002

First QC Date

June 13, 2002

Last Update Submit

June 23, 2005

Conditions

AnemiaCervix Neoplasms

Keywords

Cervical cancer

Interventions

NESP - Novel Erythropoiesis Stimulating ProteinDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sylvester Comprehensive Cancer Center/JMH

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

AnemiaUterine Cervical Neoplasms

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

June 13, 2002

First Posted

June 17, 2002

Study Start

September 1, 2001

Study Completion

March 1, 2003

Last Updated

June 24, 2005

Record last verified: 2002-06

Locations

US(1)