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

Information source: James Graham Brown Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia

Intervention: Epoetin Alfa plus Iron (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: James Graham Brown Cancer Center

Official(s) and/or principal investigator(s):
Goetz H Kloecker, MD, Principal Investigator, Affiliation: James Graham Brown Cancer Center, Univeristy of Louisville

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.

Clinical Details

Official title: A Phase II Trial Using Intravenous Iron in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia Treated With 120,000 Units Epoetin Alfa Every Three Weeks

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Achieve hemoglobin responses > 2g/dl in at least 70% of patients

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

James Graham Brown Cancer Center, Louisville, Kentucky 40202, United States
Additional Information

James Graham Brown Cancer Center, Louisville, KY

Starting date: May 2007
Last updated: May 14, 2013

Page last updated: August 23, 2015

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