Advanced Solid Tumor Malignancies Clinical Trial
Official title:
A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies
PRIMARY OBJECTIVES:
I. To document the toxicities, and reversibility of toxicities, of this regimen of
5-azacytidine (azacitidine) and erlotinib (erlotinib hydrochloride).
SECONDARY OBJECTIVES:
I. To determine any potential anti-tumor effects, as determined by the objective tumor
response (complete and partial responses), clinical benefit (complete and partial responses,
and clinical benefit), the time to tumor response, the time to tumor progression, and the
overall survival.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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