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

Phase 2

Withdrawn

• Conditions: Anemia
• Interventions: Drug: Epoetin Alfa plus Iron

• Registration Number: NCT00481624
• Lead Sponsor: University of Louisville

Brief 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.

Detailed Description

There are more than 170,000 patients diagnosed with lung cancer in the United States each year and many will develop anemia (iron deficiency) during the course of treatment. Anemia is associated with poor quality of life and treatment delays for advanced lung cancer. The treatment of iron deficiency anemia is with iron. Iron is an essential mineral used in red blood cells to carry oxygen throughout the body. Iron is necessary to make hemoglobin, a key element in red blood cells.

The FDA has approved Procrit® (epoetin alfa) to treat anemia in people with non-myeloid (bone marrow) malignancies. Procrit® is a man-made, injectable drug for treating anemia and it encourages red cell production. While the administration of intravenous iron therapy, injected into veins through an IV, did increase the response rate of Procrit® in a previous study, researchers want to find out the best amount of drug to use and the best time to administer Procrit®, along with ferric gluconate, (Ferrlecit®), added for lack of iron.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-01
• Study First Submitted QC: 2007-06-01
• Study First Posted: 2007-06-04
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion 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

Exclusion 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epoetin Alfa plus Iron	Epoetin Alfa plus Iron	-

Primary Outcome Measures

Name	Time	Method
Achieve hemoglobin responses > 2g/dl in at least 70% of patients	Nine weeks, after at least two doses of 120,000 units epoetin alfa

Secondary Outcome Measures

Name	Time	Method
Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks	Patient follow up until week 12

Trial Locations

Locations (1)

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States