| General information |
| Database: | DB00532 |
| Objective: | Thisphase I study evaluated the combination of erlotinib and 5azacytidine for safety and maximal tolerated dose (MTD). |
| Authors: | Bauman J, et al |
| Title: | a phase I study of 5azacytidine and erlotinib in advanced solid tumor malignancies. |
| Journal: | Cancer Chemother Pharmacol |
| Year: | 2012 |
| PMID: | 21901396 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | advanced solid tumors |
| Cancer Subtype: | advanced solid tumors |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | 5azacytidine and erlotinib |
| Study Type: | a phase I study |
| Key Patients Feature: | All patients were required to have a histologic diagnosis of a solid tumor malignancy that was either locally advanced and incurable or metastatic. All were required to have disease which had been previously treated and/or for which there was no acceptable standard treatment regimen. All were appropriate candidates for treatment, with an Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to 2 at the time of the initiation of therapy, adequate endorgan function, no severe comorbidity, and ability to provide informed consent. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Erlotinib was dosed at 150 mg daily, and 5azacytidine was escalated by increasing the number of daily doses of 75 mg/m(2) per cycle. |
| Primary End Point: | doselimiting toxicity (DLT). Efficacy |
| Secondary End Point: | NA |
| Patients Number: | 30 |
| Trial Results |
| DLT_MTD: | DLTs included conjunctivitis in cohort 1 and infusion reaction in cohort 2. No DLTs occurred in cohorts 3, 4, or 5; however, 2 serious neutropenic infections arose in cohort 5 after cycle 1. Cohort 4 was expanded to 6 patients and was the MTD. |
| Objective Response Rate: | Partial response (lung, ovarian) and stable disease occurred in 2 and 11 patients, respectively. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | The combination of erlotinib and 5azacytidine was well tolerated with interesting clinical activity in lung, head and neck, and ovarian cancer. The recommended dose forphase II study is erlotinib 150?mg daily and 5azacytidine 75 mg/m(2) daily on days 14 and 1518 of a 28day cycle. |