| General information |
| Database: | DB00397 |
| Objective: | Concurrent inhibition of epidermal growth factor receptor (EGFR) and cyclooxygenase2 (COX2) is an active and well tolerated regimen in recurrent head and neck cancer (HNC). In the currentphase 1 trial, the authors sought to determine the maximum tolerated dose (MTD) and efficacy of concurrent erlotinib and celecoxib as a radiosensitizing regimen. |
| Authors: | Kao J, et al |
| Title: | Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer. |
| Journal: | Cancer. |
| Year: | 2011 |
| PMID: | 21246519 |
| Trial Design |
| Clinical Trial Id: | NCT00970502 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | concurrent erlotinib, celecoxib, and reirradiation |
| Study Type: | phase I trial |
| Key Patients Feature: | Eligible patients had a biopsyproven, malignant neoplasm located in the head and neck with no evidence ofdistant metastases. Measurable disease was not required.The patients had received previous radiation to the headand neck. patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status 2 with adequate bone marrow function (white blood cellcount 1500/lL, platelets 100, 000/lL), kidney function (creatinine <1.5 g/dL), liver function (bilirubin 1.5 mg/dL, transaminase concentrations >2.5 times theupper limit of normal, and INR 1.5 times the upperlimit of normal), and lung function (oxygen saturation>95% on room air). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Treatment consisted of daily erlotinib 150 mg and twice daily celecoxib (escalated from 200 mg to 600 mg using a 3 + 3 design with an expanded cohort at the MTD) starting on Day 1 and was continued during radiation. Daily radiation was started on Day 15, and maintenance erlotinib was recommended. |
| Primary End Point: | the DLT of the regimen and to define a recommended phase 2 dose. |
| Secondary End Point: | The time to progression |
| Patients Number: | 14 |
| Trial Results |
| DLT_MTD: | The recommendedphase 2 dose of celecoxib was 400 mg. Three doselimiting toxicities included late infieldorocutaneous fistula (Dose Level 2), osteonecrosis (Dose Level 3), and trismus (Dose Level 3). Acute grade 3toxicities were uncommon and included mucositis (21%) and dermatitis (14%). |
| Objective Response Rate: | At a median followup of 11 months, the 1year locoregional control, progression free survival, and overall survival rates were 60%, 37%, and 55%, respectively. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | the 1year progression free survival rate: 37% |
| Median OS A vs. C: | the 1year survival was 55% |
| Adverse Event(agent arm): | The most common acute grade 3 toxicities were mucositis (21% of patients), pain (21% of patients), fatigue (21% of patients), dermatitis (7% of patients), and hyponatremia (7% of patients). |
| Conclusions: | Concurrent erlotinib, celecoxib, and reirradiation was a feasible and clinically active regimen in a population of patients with recurrent HNC who had a poor prognosis. |