Using Iron With Procrit in Advanced Lung Cancer Patients... | NCT00481624

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

NCT00481624

Sponsor

University of Louisville

Status

Withdrawn

Last Update Posted

Mar 5, 2018Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Anemia

Interventions

Epoetin Alfa plus Iron

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was stopped because of lack of funding.

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Jun 1, 2007

First Submission Date that Met QC Criteria

Jun 1, 2007

First Posted Date

Jun 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2018

Last Update Posted Date

Mar 5, 2018Actual

Name	Class
James Graham Brown Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epoetin Alfa plus Iron	Experimental		Drug: Epoetin Alfa plus Iron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epoetin Alfa plus Iron	Drug	One (1) injection of Procrit®, by needle, inserted just under the skin; 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Goetz H Kloecker, MD	James Graham Brown Cancer Center, Univeristy of Louisville	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
James Graham Brown Cancer Center		Louisville	Kentucky	40202	United States

Label	URL
James Graham Brown Cancer Center, Louisville, KY	View source

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068817	Epoetin Alfa
D007501	Iron
C035552	ferric gluconate

Ancestor Terms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided