Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anemia Cervix Neoplasms

Keywords

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Cervical cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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NESP - Novel Erythropoiesis Stimulating Protein

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Locations

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Sylvester Comprehensive Cancer Center/JMH

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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01/155A

Identifier Type: -

Identifier Source: org_study_id