Entry Detail
| General information | |
| Database: | DB00385 |
| Objective: | To determine the efficacy and safety of singleagent sorafenib in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) and nasopharyngeal carcinoma (NPC). |
| Authors: | Elser C, et al |
| Title: | Phase II trial of sorafenib in patients with recurrent or metastatic squamous cell carcinoma of the head and neck or nasopharyngeal carcinoma. |
| Journal: | J Clin Oncol. |
| Year: | 2007 |
| PMID: | 17704426 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | sorafenib |
| Target: | Vascular endothelial growth factor receptor 1 BRaf protooncogene serine/threonineprotein kinase Protooncogene tyrosineprotein kinase receptor ret |
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a singlearmphase II trial |
| Key Patients Feature: | Patients enrolled onto this study had histologically confirmed, recurrentand/or metastatic HNSCC or NPC and had received no more than one priorsystemic therapy for recurrent and/or metastatic disease. Prior chemotherapyas part of the initial curative treatment was permitted. Patients were requiredto be at least 18 years old, have an Eastern Cooperative Oncology Groupperformance status of 0 to 2, and have measurable disease. Adequate organfunction was required as defined by ALT and AST 2.5 the upper limit ofnormal (ULN; patients with metastatic liver involvement 5 ULN); bilirubin, amylase, lipase, creatinine 1.5 ULN; and prothrombin time or international normalized ratio and partial thromboplastin time less than 1.5 ULN. Prior use of farnesyltransferase, Raf kinase, or MEK inhibitors was notallowed. Significant surgery, myelosuppressive radiotherapy, or drugs that target VEGF were not allowed within 4 weeks before the start of study. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | oral continuous sorafenib was administered in 28day cycles |
| Primary End Point: | response rate. |
| Secondary End Point: | assessment of stable disease rate, time to progression (TTP)of disease, overall survival (OS), toxicity profile, and evaluation of pharmacodynamic markers. |
| Patients Number: | 27 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | Onepatient (3.7%; 95% CI, 0.1% to 19.0%) achieved a partial response. |
| Disease Control Rate: | 37.0% (95% CI, 19.4% to 57.6%) |
| Median Time to Progression: | 1.8 months (95% CI, 1.6 to 3.4 months) |
| Median PFS A vs. C: | the 6month progression free survival rate was 3.9% (95%CI, 0.6% to 26.4%) |
| Median OS A vs. C: | 4.2 months (95% CI, 3.6 to 8.7 months). |
| Adverse Event(agent arm): | Sorafenib was well tolerated with few grade 3 and no grade 4 toxicities. |
| Conclusions: | Sorafenib was well tolerated and had modest anticancer activity comparable to monotherapy with other targeted agents in this group of patients. Further development in combination with radiation or other agents may be warranted. |