Effect of Iron Therapy as an Adjunct to Epoetin Alfa in the Anemia of Cancer Chemotherapy

A Multicenter, Randomized, Controlled Prospective Trial of the Safety and Efficacy of Ferrlecit® in Anemic Cancer Patients Who Are Receiving Acute Chemotherapy and Epoetin as Compared to Oral Iron and No Treatment

Sponsors

Lead Sponsor: Watson Pharmaceuticals

Source Watson Pharmaceuticals
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.

Overall Status Completed
Start Date May 2002
Completion Date December 2003
Primary Completion Date December 2003
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in hemoglobin
Secondary Outcome
Measure Time Frame
Change in various iron indices
Enrollment 180
Condition
Intervention

Intervention Type: Drug

Intervention Name: Sodium ferric gluconate, ferrous sulfate, standard of care

Eligibility

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Highly elevated TSAT or ferritin

- Recent transfusion, epoetin alfa, darbepoetin or intravenous iron

- Medical conditions that would confound the efficacy evaluation

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Naomi V. Dahl, Pharm.D. Study Director Watson Laboratories, Inc.
Location
Facility:
| Bakersfield, California, United States
| Chula Vista, California, United States
| Long Beach, California, United States
| Los Angeles, California, United States
| Norwich, Connecticut, United States
| Port St Lucie, Florida, United States
| Zephyrhills, Florida, United States
| Columbus, Georgia, United States
| Coeur d'Alene, Idaho, United States
| Hutchinson, Kansas, United States
| Lexington, Kentucky, United States
| Baton Rouge, Louisiana, United States
| Baltimore, Maryland, United States
| Detroit, Michigan, United States
| Southfield, Michigan, United States
| St Joseph, Michigan, United States
| Duluth, Minnesota, United States
| Greenwood, Mississippi, United States
| Cherry Hill, New Jersey, United States
| Denville, New Jersey, United States
| Manhasset, New York, United States
| Bismarck, North Dakota, United States
| Columbus, Ohio, United States
| Philadelphia, Pennsylvania, United States
| Pittsburgh, Pennsylvania, United States
| West Chester, Pennsylvania, United States
| Columbia, South Carolina, United States
| Laredo, Texas, United States
| Richmond, Virginia, United States
| Salem, Virginia, United States
| Walla Walla, Washington, United States
| Milwaukee, Wisconsin, United States
Location Countries

United States

Verification Date

February 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov