A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies
Part of paid clinical trials in Albuquerque, New Mexico.
- Sponsor
- New Mexico Cancer Research Alliance
- Study ID
- NCT00996515
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Solid Tumor Malignancies
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 5-azacytidine, erlotinib — DRUGErlotinib 150 mg PO daily, days 1-8, and 15-22 5-Azacytidine 75 mg/m2/day, IV days 1 and 15
- Erlotinib PO and Vidaza IV — DRUGPatients enrolled to 1 of 5 cohorts, with varying drug doses and dose scheduling.
Study Details
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.
Key Dates
- First listed
- Oct 16, 2009
- Start date
- Jun 30, 2008
- Status verified
- Apr 2013
- Primary completion
- Jul 31, 2011
- Completion
- Sep 30, 2011
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 5Erlotinib 150mg/day PO Day 1-28 and Vidaza 100mg/m2/day SQ Day 1-4 and 15-18
- Experimental: Cohort 4Erlotinib 200 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day SQ 1-4 and 15-18
- Experimental: Cohort 3Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1-3 and 15-17
- Experimental: Cohort 2Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1-2 and 15-16
- Experimental: Cohort 1Erlotinib 150 mg/day PO Day 1-28 and Vidaza 75 mg/m2/day IV Day 1 and 15
Primary 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. [ Time Frame: 4 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | - |
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