IV Iron vs No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy - Full Text View

Sponsored by:	Luitpold Pharmaceuticals
Information provided by:	Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00236951

Purpose

To assess the change in Hgb levels when iron sucrose is added to a regimen of weekly, fixed doses of erythropoietin in patients who have responded to erythropoietin therapy alone.

Condition	Intervention	Phase
Anemia	Drug: iron sucrose injection USP Drug: stable erythropoietin therapy	Phase III

MedlinePlus related topics: Anemia Cancer

Drug Information available for: Epoetin alfa Erythropoietin Sucrose Ferric oxide, saccharated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:

Maximum change in Hgb from randomization

Secondary Outcome Measures:

Hemoglobin Response Rate
Time from randomization to Maximum Hgb Improvement
Duration of Hgb Response
Need for intervention
FACIT Fatigue Scale
Change from baseline in iron indices
Change in Tumor response
Incidence of adverse events

Estimated Enrollment:	325
Study Start Date:	February 2003
Estimated Study Completion Date:	December 2005

Detailed Description:

This is a two stage, randomized controlled study of cancer patients undergoing chemotherapy. After stage one, where patents are exposed to an erythropoiesis stimulating agent, patients will be randomized to receive either IV iron sucrose or no iron supplementation. Patients will them be followed to safety and efficacy endpoints.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236951

Sponsors and Collaborators

Luitpold Pharmaceuticals

Investigators

Study Director:

Robert Bellet, MD

Luitpold Pharmaceuticals

More Information

Study ID Numbers:	1VEN02023
Study First Received:	October 10, 2005
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00236951
Health Authority:	United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:

Anemia
Cancer
Chemotherapy

Study placed in the following topic categories:

Epoetin Alfa
Ferric oxide, saccharated
Hematologic Diseases
Anemia
Iron

Additional relevant MeSH terms:

Hematinics
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Hematologic Agents
Trace Elements
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009