Clinical trial NCT00481624: Using Iron With Procrit in Advanced Lung Cancer Patients With Chemotherapy-Induced Anemia
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Anemia
Keywords: advanced lung cancer
Procrit
Epoetin Alfa
Ferric Gluconate
iron supplementation
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2007-06-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Achieve hemoglobin responses > 2g/dl in at least 70% of patients
timeFrame: Nine weeks, after at least two doses of 120,000 units epoetin alfa
Secondary outcomes:
measure: Descriptive evaluation of adverse effects of parenteral iron and epoetin alfa 120,000 units given every three weeks
timeFrame: Patient follow up until week 12
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center, Univeristy of Louisville
name: Goetz H Kloecker, MD
role: PRINCIPAL_INVESTIGATOR
References: