| General information |
| Database: | DB00553 |
| Objective: | The benefit of salvage chemotherapy is modest in metastatic urothelial cancer. They conducted a randomized, noncomparativephase II study to measure the efficacy of cetuximab with or without paclitaxel in patients with previously treated urothelial cancer. |
| Authors: | Wong YN, et al |
| Title: | Phase II trial of cetuximab with or without paclitaxel in patients with advanced urothelial tract carcinoma. |
| Journal: | J Clin Oncol. |
| Year: | 2012 |
| PMID: | 22927525 |
| Trial Design |
| Clinical Trial Id: | NCT00350025 |
| Agent: | Cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | Urothelial Carcinoma |
| Cancer Subtype: | urothelial cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab with or without paclitaxel |
| Study Type: | randomized, noncomparativephase II study |
| Key Patients Feature: | patients were enrolled who were older than age 18 years, had ahistologically confirmed diagnosis of urothelial cancer, and radiographic evidence of metastases. Mixed histologies were allowed provided theyincluded a component of urothelial cancer. Patients must have had progressive disease after therapy for advanced disease or progressive diseaseafter perioperative (neoadjuvant or adjuvant) therapy. There was no restriction on the time from previous therapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | cetuximab with or without paclitaxel |
| Treatment Info: | patients were randomly assigned to 4week cycles of cetuximab 250 mg/m(2) with or without paclitaxel 80 mg/m(2) per week. They used early progression as an indicator of futility. Either arm would close if seven of the initial 15 patients in that arm progressed at the first disease evaluation at 8 weeks. |
| Primary End Point: | PFS |
| Secondary End Point: | NA |
| Patients Number: | 39 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The overall response rate was 25% (95% CI, 11% to 45%; three complete responses and four partial responses). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 16.4 weeks (95% CI, 12 to 25.1 weeks) |
| Median OS A vs. C: | 42 weeks (95% CI, 30.4 to 78 weeks). |
| Adverse Event(agent arm): | Treatmentrelated grade 3 and 4 adverse events that occurred in at least two patients were rash (six cases), fatigue (five cases), and low magnesium (three cases). |
| Conclusions: | Although it had limited activity as a single agent, cetuximab appears to augment the antitumor activity of paclitaxel in previously treated urothelial cancers. The cetuximab and paclitaxel combination merits additional study to establish its role in the treatment of urothelial cancers. |