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

NCT00481624 | Withdrawn Phase 2 DMC

• 1 other identifier: 07.0210
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Keywords

advanced lung cancer; Procrit; Epoetin Alfa; Ferric Gluconate; iron supplementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks

  Patient follow up until week 12

Study Arms (1)

Epoetin Alfa plus Iron

EXPERIMENTAL

Drug: Epoetin Alfa plus Iron

Interventions

Epoetin Alfa plus Iron 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.

Also known as: Procrit®; Ferrlecit®

Epoetin Alfa plus Iron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Links

• James Graham Brown Cancer Center, Louisville, KY

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa; Iron; ferric gluconate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Goetz H Kloecker, MD

  James Graham Brown Cancer Center, Univeristy of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (1)