NCT00224068

Brief Summary

This study evaluates the safety and efficacy of Ferrlecit® (ferric gluconate; a form of intravenous iron) or ferrous sulfate (a form of oral iron) in improving the response to epoetin alfa among anemic cancer patients receiving chemotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2002

Geographic Reach
1 country

32 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

March 2, 2012

Status Verified

February 1, 2012

Enrollment Period

1.6 years

First QC Date

September 13, 2005

Last Update Submit

February 29, 2012

Conditions

Anemia

Keywords

Iron deficiencySodium ferric gluconateanemiacancer chemotherapyepoetin alfaAnemia/drug therapyAnemia, Iron-Deficiency/drug therapy/etiologyHematinics/administration & dosage/pharmacologyAntineoplastic Agents/adverse effectsErythropoietin, Recombinant/therapeutic use/adverse effects

Outcome Measures

Primary Outcomes (1)

  • Change in hemoglobin

Secondary Outcomes (1)

  • Change in various iron indices

Interventions

Sodium ferric gluconate, ferrous sulfate, standard of careDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of nonmyeloid malignancy
  • Moderate to severe anemia
  • Adequate iron stores as measured by either TSAT or ferritin
  • About to start cycle of chemotherapy
  • Eligible for epoetin alfa therapy

You may not qualify if:

  • Highly elevated TSAT or ferritin
  • Recent transfusion, epoetin alfa, darbepoetin or intravenous iron
  • Medical conditions that would confound the efficacy evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Unknown Facility

Bakersfield, California, United States

Location

Unknown Facility

Chula Vista, California, United States

Location

Unknown Facility

Long Beach, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Norwich, Connecticut, United States

Location

Unknown Facility

Port Saint Lucie, Florida, United States

Location

Unknown Facility

Zephyrhills, Florida, United States

Location

Unknown Facility

Columbus, Georgia, United States

Location

Unknown Facility

Coeur d'Alene, Idaho, United States

Location

Unknown Facility

Hutchinson, Kansas, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Baton Rouge, Louisiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Saint Joseph, Michigan, United States

Location

Unknown Facility

Southfield, Michigan, United States

Location

Unknown Facility

Duluth, Minnesota, United States

Location

Unknown Facility

Greenwood, Mississippi, United States

Location

Unknown Facility

Cherry Hill, New Jersey, United States

Location

Unknown Facility

Denville, New Jersey, United States

Location

Unknown Facility

Manhasset, New York, United States

Location

Unknown Facility

Bismarck, North Dakota, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

West Chester, Pennsylvania, United States

Location

Unknown Facility

Columbia, South Carolina, United States

Location

Unknown Facility

Laredo, Texas, United States

Location

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Salem, Virginia, United States

Location

Unknown Facility

Walla Walla, Washington, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Related Publications (1)

  • Henry DH, Dahl NV, Auerbach M, Tchekmedyian S, Laufman LR. Intravenous ferric gluconate significantly improves response to epoetin alfa versus oral iron or no iron in anemic patients with cancer receiving chemotherapy. Oncologist. 2007 Feb;12(2):231-42. doi: 10.1634/theoncologist.12-2-231.

    PMID: 17296819RESULT

MeSH Terms

Conditions

AnemiaIron Deficiencies

Interventions

ferric gluconateferrous sulfateStandard of Care

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Naomi V. Dahl, Pharm.D.

    Watson Laboratories, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

May 1, 2002

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

March 2, 2012

Record last verified: 2012-02

Locations

US(32)