Entry Detail
| General information | |
| Database: | DB00388 |
| Objective: | They conducted a phase II trial to evaluate the efficacy and safety of singleagent sorafenib in chemotherapyna ve patients with metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN). The primary end point was response probability (ie, confirmed complete and partial response [PR]). |
| Authors: | Williamson SK, et al |
| Title: | Phase II evaluation of sorafenib in advanced and metastatic squamous cell carcinoma of the head and neck: Souththeyst Oncology Group Study S0420 |
| Journal: | J Clin Oncol. |
| Year: | 2010 |
| PMID: | 20498388 |
| Trial Design | |
| Clinical Trial Id: | NCT00096512 |
| 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: | phase II trial |
| Key Patients Feature: | Patients with histologically proven SCCHN that was metastatic at diagnosis or that persisted, metastasized, or recurred after definitive therapy andthat was not amenable to surgical resection were eligible. Newly diagnosed patients with nonmetastatic disease were not eligible. Patients must not havereceived prior chemotherapy for recurrent or newly diagnosed metastaticdisease but could have received one induction or adjuvant chemotherapy, provided at least 6 months had elapsed since the last course of chemotherapy.Prior radiation and surgery must have been completed at least 28 days beforeregistration. Patients were required to have a Zubrod performance status (PS)of 0 or 1 and measurable disease as defined per Response Evaluation Criteria inSolid Tumors (RECIST)25; no other concurrent antitumor therapy was allowed while on study. All patients had to have adequate renal function (ie, serum creatinine two times the institutional upper limit of normal; adequate hematologic values (ie, granulocyte count 1, 500/mm3, plateletcount 100, 000/mm3); and adequate hepatic function, (ie, bilirubin, alkalinephosphatase, and AST or ALT two times the institutional upper limit ofnormal). |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Sorafenib was administered orally at 400 mg twice daily on a continuous basis in 28day cycles. Responses were evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors). |
| Primary End Point: | response probability (ie, confirmed complete and partial response [PR]). |
| Secondary End Point: | The disease control rate, the PFS and OS rates (ie, secondary end points). |
| Patients Number: | 41 |
| Trial Results | |
| DLT_MTD: | Of the 41 eligible patients assessed for adverse events, one experienced a grade 4 adverse event as a result of an asymptomatic pulmonary embolus. Themost common grades 2 to 3 adverse events were fatigue, anorexia, stomatitis/oral pain, abdominal pain, handfoot syndrome, weight loss, and hypertension. |
| Objective Response Rate: | There was one confirmed PRand two unconfirmed PRs. The estimated confirmed response probability was 2% (95% CI, 0%to 13%).The estimated median progression free survival was 4 months (95% CI, 2 to 4 months), and the estimated median overall survival was 9 months (95% CI, 7 to 14 months |
| Disease Control Rate: | 51% (95% CI, 35% to 67%) |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4 months (95% CI, 2 to 4 months) |
| Median OS A vs. C: | 9 months (95% CI, 7 to 14 months) |
| Adverse Event(agent arm): | Sorafenib was generally well tolerated. Of the 41 eligible patients assessed for adverse events, one experienced a grade 4 adverse event as a result of an asymptomatic pulmonary embolus. The most common grades 2 to 3 adverse events were fatigue, anorexia, stomatitis/oral pain, abdominal pain, handfoot syndrome, weight loss, and hypertension. |
| Conclusions: | Sorafenib was well tolerated. Although response was poor, progression free and overall survival times compare favorably with previous Souththeyst Oncology Group,phase II, singleagent trials. |