Entry Detail
| General information | |
| Database: | DB00365 |
| Objective: | There are limited chemotherapeutic options for advanced recurrent or metastatic SCCHN. The efficacy and toxicity of docetaxel with or without vandetanib was investigated in these patients. |
| Authors: | Limaye S, et al |
| Title: | A randomizedphase II study of docetaxel with or without vandetanib in recurrent or metastatic squamous cell carcinoma of head and neck (SCCHN). |
| Journal: | Oral Oncol. |
| Year: | 2013 |
| PMID: | 23727257 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | vandetanib |
| Target: | Epidermal growth factor receptor Vascular endothelial growth factor receptor 2 Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | docetaxel with vandetanib |
| Study Type: | randomizedphase II study |
| Key Patients Feature: | Patients above 18 years of age, with pathologically confirmedrecurrent/metastatic SCCHN with evaluable disease, not amenableto primary surgical resection or radiotherapy, were eligible for thestudy. Patients could have received up to one line of chemotherapyfor recurrent/metastatic disease prior to enrollment. Patients withSCCHN of unknown primary were allowed to participate. Patientsmust have received a platinum based regimen as definitive or palliative therapy prior to enrolling. They could have received amonoclonal antibody EGFR inhibitor such as cetuximab. They wereexpected to have a life expectancy of at least 3 months and an COG performance status of 0-2. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:14 in docetaxel arm B: 15 in combined arm |
| Treatment Info: | patients were randomized in this open label, multicenterphase II study of docetaxel (75 mg/m2 IV Q3 weeks) with or without vandetanib (100 mg PO daily). |
| Primary End Point: | response rate (RR) |
| Secondary End Point: | progression free survival (PFS), overall survival (OS), disease control rate (DCR) and duration of response (DOR). |
| Patients Number: | 29 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | PR was achieved in 1 patient in the docetaxel arm and 2 patients in the combined arm.The objective RR was 7% (1/14) (95% CI 0.233.8%) in the single and 13% (2/15) (95% CI 1.640.4%) combined arm |
| Disease Control Rate: | 28.6% (4/14) and 60% (9/15) in the single and combined arms respectively. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | in docetaxel arm and in combined arm: 3.21 (95% CI 3.0-22.0) and 9 (95% CI (5.86-18.1) weeks |
| Median OS A vs. C: | in docetaxel arm and in combined arm: 26.8(95% CI 17.7- 100.7+) and 24.1 (95% CI, 16.4-171.1+) weeks. |
| Adverse Event(agent arm): | Most common adverse events were fatigue, dysphagia, diarrhea or constipation, cytopenias and alopecia. |
| Conclusions: | Although an initial benefit in response was noted and statistical criteria met there was only a minor trend towards improved PFS for the combined arm. The study was designed with low threshold for activity in each arm and results they were deemed not to be of enough clinical significance in this group of patients to continue accrual. |