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OpenTrials
Completed

NCT Number: NCT00236951

Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological Diagnosis of Cancer
  • Hgb </= 10
  • Ongoing or Planned Chemotherapy
  • Body Weight >50kg
  • Free of Active Infection
  • Karnofsky Status 60% to 100%

Exclusion criteria

  • Active infection
  • Use of Multivitamins with iron within one week of entry
  • Myelophthisic bone marrow involvement by tumor except hematologic malignancy
  • Concurrent medical condition that would prevent compliance or jeopardize the health of the patient
  • Use of any IV iron products within two months of study entry
  • Blood Transfusions
  • Hypoplastic bone marrow failure state
  • Acute Leukemia
  • Myeloproliferative syndrome
  • Uncontrolled hypertension

Treatment and study plan

iron sucrose injection USP

Drug

stable erythropoietin therapy

Drug

Primary outcomes

  1. Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).

    Time frame: During Stage 2 (week 9 through week 21)

    The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8).

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 12, 2005
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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