The Role of Erlotinib an Epidermal Growth Factor Receptor (EGFR) Inhibitor in the Treatment of Myelodysplastic Syndrome

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT00570375
Phase
PHASE2
Status
Withdrawn

Conditions

  • Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    150 mg, PO, QD beginning day 1 week 1. Patients will receive treatment for 16 weeks as long as there is no evidence of disease progression. In no response is noted after 16 weeks of treatment, patients will be taken off the study. Patients achieving response (HI, CR, or PR) will continue on treatment until evidence of disease progression or relapse.

Study Details

The purpose of this research study is to find out what effects, good and/or bad, Erlotinib has on Myelodysplastic syndrome. Myelodysplastic syndrome is a group of blood diseases where the bone marrow (spongy space in long bones which is the factory for blood cell production) does not make enough blood cells and therefore there is a lack of healthy blood cells in the body. This can result in anemia, risk for infection and/or bleeding..

Key Dates

First listed
Dec 10, 2007
Start date
Nov 30, 2007
Status verified
Apr 2009
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    All patients will receive 150 mg of Erlotinib

Primary Outcome Measure

First 20 patients will be evaluated for overall response rate (CR, PR or HI). [ Time Frame: Estimated to be about 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45267-

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By research site
University of Cincinnati· Cincinnati, OH

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