| General information |
| Database: | DB00348 |
| Objective: | To evaluate the efficacy and safety of the epidermal growth factor receptordirected monoclonal antibody cetuximab administered as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) who experience disease progression on platinum therapy. |
| Authors: | Vermorken JB, et al |
| Title: | Openlabel, uncontrolled, multicenterphase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinumbased therapy. |
| Journal: | J Clin Oncol. |
| Year: | 2007 |
| PMID: | 17538161 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | EGFR
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | openlabel, uncontrolled, multicenterphase II study |
| Key Patients Feature: | ligibility required histologically confirmed stage III/IV metastatic orrecurrent SCCHN (according to American Joint Committee on Cancer) thatwas not suitable for local therapy, with documented PD within 30 days after aminimum of two and a maximum of six cycles of cisplatinbased ( 60mg/m2/cycle) or carboplatinbased ( 300 mg/m2/cycle, or area under thetimeconcentration curve 4) chemotherapy. Additional patient eligibilitycriteria included age 18 years; Karnofsky performance status (KPS) 60%;measurable disease; tumor tissue available for immunohistochemical (IHC)staining of EGFR expression; and adequate hematologic, renal, and hepaticfunction. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients with disease progression on two to six cycles of platinum therapy received singleagent cetuximab (initial dose 400 mg/m2 follotheyd by subsequent weekly doses of 250 mg/m2) for > or = 6 weeks (singleagentphase). Patients who experienced disease progression could receive salvage therapy with cetuximab plus platinum (combinationtherapyphase). |
| Primary End Point: | the best overall response rate (complete responses [CRs] and partial responses [PRs]). |
| Secondary End Point: | disease control rate (best response of either CR, PR, or SD), time to and duration of response, duration of response, time to progression, overall survival, and changes in KPS from baseline. |
| Patients Number: | 103 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The best overall response and disease control rates were 13% (95% CI, 7% to 21%) and 46% (95%CI, 36% to 56%), respectively. No patient achieved a best response of CR in either population |
| Disease Control Rate: | 46% in the singleagentphase. 26% in the combination therapyphase. |
| Median Time to Progression: | 49 days (range, 37 to 251 days) |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 178 days |
| Adverse Event(agent arm): | The most common cetuximabrelated adverse events in the singleagentphase were skin reactions, particularly rash (49% of patients, mainly grade 1 or 2). There was one treatmentrelated death due to an infusionrelated reaction. |
| Conclusions: | Singleagent cetuximab was active and generally well tolerated in the treatment of recurrent andor metastatic SCCHN that progressed on platinum therapy. Response was comparable to that seen with cetuximab plus platinum combination regimens in the same setting. |