NCT00996515

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	5-azacytidine, erlotinib	Erlotinib 150 mg PO daily, days 1-8, and 15-22 5-Azacytidine 75 mg/m2/day, IV days 1 and 15
DRUG	Erlotinib PO and Vidaza IV	Patients enrolled to 1 of 5 cohorts, with varying drug doses and dose scheduling.

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-07-01
• Completion: 2011-09-01
• First posted: 2009-10-16
• Last updated: 2013-05-01

Locations

1 site across 1 country: United States