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

NCT ID: NCT00481624

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-11-30

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.

Conditions

Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epoetin Alfa plus Iron

Group Type: EXPERIMENTAL

Epoetin Alfa plus Iron

Intervention Type: DRUG

1. One (1) injection of Procrit®, by needle, inserted just under the skin;

2. 125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein.

These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.

In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan.

Interventions

Epoetin Alfa plus Iron

1. One (1) injection of Procrit®, by needle, inserted just under the skin;

2. 125 mg of ferric gluconate (an iron injection product), through an IV injection into a vein.

These injections will take approximately 10-15 minutes to complete. Both will be administered every 3 weeks for a total of 4 cycles, unless the study doctor decides that a change in the amount of Procrit® and iron is necessary once the hemoglobin level rises or is above a certain amount.

In addition to Procrit® and the intravenous iron, the subject will also receive platinum-containing chemotherapy every 3 weeks for 4 cycles as per standard of care for their lung cancer treatment. Radiation therapy will be allowed during this regimen if it is part of the subject's treatment plan.

Intervention Type: DRUG

Other Intervention Names

Procrit®; Ferrlecit®

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Goetz Kloecker

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Goetz H Kloecker, MD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center, Univeristy of Louisville

Locations

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Countries

United States

Related Links

http://www.browncancercenter.org

James Graham Brown Cancer Center, Louisville, KY

Other Identifiers

07.0210

Identifier Type: -

Identifier Source: org_study_id