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Phase II of Erlotinib an Epidermal Growth Factor Receptor Inhibitor in the Treatment of Myelodysplastic Syndrome

Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndrome

Thank you

Trial Information

Phase II of Erlotinib an Epidermal Growth Factor Receptor Inhibitor in the Treatment of Myelodysplastic Syndrome

MDS is a neoplastic clonal stem disorder characterized by bone marrow failure with
cytopenia, dyslastic morphological features and tendency to progress to acute myeloid
leukemia. It is estimated that MDS is the most common hematological malignancy in the USA.
Several treatment options are available for MDS ranging from supportive care, growth factor
use, chemotherapy, stem cell transplantation, and newer novel agents such as thalidomide,
lenalidomide, and hypomethylating agents. Each of the different available treatments for
MDS work in certain subset and relatively small percentage of patients, keeping the door
open for novel therapeutic strategies to be explored. The NIH has published requests for
applications on myeloproliferative and myelopdysplastic syndrome emphasizing the need for
more research in this area.

Inclusion Criteria:

- Patients must have an established diagnosis of myelodysplastic syndrome (MDS) and
have either symptomatic anemia (defined as hemoglobin less than 10.0 g/dl) or
transfusion dependent anemia (defined as 4 units of blood in the last 60 days).

- Patients treated previously with 5-azacytidine, decitabine, thalidomide, revlimid,
amifostine, hydroxyurea, Histone deacytlase inhibitors and arsenic trioxide are
allowed. Prior treatment with cytokines (i.e., interferon, interleukin), colony
stimulating factors, or hydroxyurea is also permitted. Patients should be 28 days off
prior treatment.

- Patients with chronic myelomonocytic leukemia (CMML) are eligible.

- Patients must have a performance status of 0 - 2 by Zubrod performance status

- Pretreatment pathology materials must be available for morphologic review.
Collection of blood and marrow specimens for pathology review must be completed
within 28 days prior to registration

- All patients must be informed of the investigational nature of this study and must
sign and give written consent in accordance with institutional and federal

Exclusion Criteria:

- Patients must not have undergone bone marrow or stem cell transplant.

- Patients must not have received prior remission induction chemotherapy as treatment
for MDS.

- Patients must not have secondary or therapy related MDS

- Patients who are known HIV positive are not eligible for this study.

- Patients must not be pregnant or nursing because of the potential risks of the drugs
used in this study. Women/men of reproductive potential may not participate unless
they have agreed to use an effective contraceptive method.

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for at least 2 years

Type of Study:


Study Design:

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

Outcome Measure:

First 20 patients will be evaluated for overall response rate (CR, PR or HI).

Outcome Time Frame:

Estimated to be about 1 year.

Safety Issue:


Principal Investigator

Carl W Siegrist, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati


United States: Institutional Review Board

Study ID:




Start Date:

November 2007

Completion Date:

November 2012

Related Keywords:

  • Myelodysplastic Syndrome
  • Blood disease, bone marrow
  • Myelodysplastic Syndromes
  • Preleukemia



University of Cincinnati Cincinnati, Ohio  45267-0502