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A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies

Phase 1
19 Years
Not Enrolling
Advanced Solid Tumor Malignancies

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Trial Information

A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies

OUTLINE: This is a dose-escalation study.

Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) on
days 1 and 15, days 1-2 and 15-16, days 1-3 and 15-17, or days 1-4 and 15-18. Patients also
receive erlotinib hydrochloride orally (PO) daily on days 1-21. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 28 days and then every 3
months for 5 years.

Inclusion Criteria:

- Patients must fulfill all of the following criteria to be eligible for study entry:

- Those who will be eligible will be all patients with non-hematologic neoplasms
(lymphomas, leukemias, myeloma, myelodysplasia, or myeloproliferative syndromes) who
have disease which has been previously treated and/or for which there is no
acceptable standard treatment regimen available, and cannot be treated definitively
with either surgery or radiotherapy. All will be appropriate candidates for
treatment, and are not candidates for treatment with protocols of higher priority.
All patients should have an ECOG/Zubrod/SWOG performance status of <2 at the time of
the initiation of therapy, adequate end-organ function, no severe comorbid disease,
and ability to provide informed consent.

Other Eligibility Criteria:

- Signed Informed Consent

- ECOG/Zubrod/SWOG Performance Status <2 (Karnofsky Performance Status > 70%)

- Life expectancy > 8 weeks

- Male or female' age >18 years

- Patients of childbearing potential must be using an effective means of contraception.

- Women of childbearing potential must have a negative serum pregnancy test prior to
azacitidine treatment.

- Histologic diagnosis of a solid tumor malignancy that is advanced and cannot be
treated adequately by radiotherapy or surgery; or metastatic disease

- Baseline laboratory values (bone marrow, renal, hepatic):

- Adequate bone marrow function:

- Absolute neutrophil count >1000/µL

- Platelet count >100'000/µL

- Renal function:

- Serum creatinine < 1.5 x ULN

- Hepatic function:

- Bilirubin <1.5x normal

- Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase
[AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase
[ALT]) levels <=2 x ULN

- Serum calcium < 12 mg/dl

Exclusion Criteria:

Patients meeting any of the following criteria are ineligible for study entry:

- Pregnant or lactating females

- Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0

- Uncontrolled' clinically significant dysrhythmia

- Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor
growth in that lesion

- Uncontrolled metastatic disease of the central nervous system

- Sensitivity to erlotinib, 5-azacytidine or mannitol

- Advanced hepatic tumors

- Radiotherapy within the 2 weeks before Cycle 1' Day 1

- Surgery within the 2 weeks before Cycle 1' Day 1

- Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications

Type of Study:


Study Design:

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

Outcome Measure:

Quality and quantity of adverse events due to administration of erlotinib + 5-azacytidine, as therapy for the treatment of advanced or metastatic cancer.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Julie E Bauman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Institutional Review Board

Study ID:

INST 0710C



Start Date:

June 2008

Completion Date:

September 2011

Related Keywords:

  • Advanced Solid Tumor Malignancies
  • Advanced Solid Tumor Malignancies
  • Erlotinib
  • Vidaza
  • Tarceva
  • 5-azacytidine
  • Neoplasms



University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636