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WithdrawnPhase 2NCT00481624
Official study title

Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia

Study summary

The purpose of this study is to find a better, more convenient way to improve anemia results by increasing the amount of medication given at 3 week intervals. Researchers want to know if giving a higher dose of Procrit® and intravenous (IV) iron once every 3 weeks would give better results in treating anemia without the need for more office visits.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEpoetin Alfa plus Iron

The study team can explain what participation involves.

Who it may be forAnemia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 5, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Louisville

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Louisville
Interventions being studied
Drug: Epoetin Alfa plus Iron
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Histologically confirmed small cell or non small cell lung cancer
  • Stage III or Stage IV lung cancer
  • Platinum containing chemotherapy induced anemia (\< 10 g/dl Hb)
  • Cancer related anemia (\<10 g/dl Hb) at time of initiation of chemotherapy
  • ECOG performance status of 0,1, or 2
  • Informed consent
  • Age\>18
  • Expected to receive platinum based outpatient chemotherapy for at least nine weeks
Reasons someone may not be able to joinExclusion criteria
  • Pregnant women
  • Intolerance to epoetin alfa or parenteral iron
  • More than 2 cycles of the planned platinum chemotherapy at time of enrollment
  • Chronic GI bleed (\> than 4 weeks positive hemoccult or gastroccult)
  • Ferritin \> 500 mg/dl
  • Anemia due to other causes than cancer or chemotherapy
  • Previous parenteral iron therapy
  • Uncontrolled hypertension (systolic BP \> 160, diastolic \> 100 mmHg)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • James Graham Brown Cancer CenterLouisville, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 5, 2018. Always confirm current availability with the study team.

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