Phase II trial of cetuximab with or without paclitaxel in patients with advanced urothelial tract carcinoma.

ABSTRACT:

Purpose

The benefit of salvage chemotherapy is modest in metastatic urothelial cancer. We conducted a randomized, noncomparative phase II study to measure the efficacy of cetuximab with or without paclitaxel in patients with previously treated urothelial cancer.

Patients and methods

Patients with metastatic urothelial cancer who received one line of chemotherapy in the perioperative or metastatic setting were randomly assigned to 4-week cycles of cetuximab 250 mg/m(2) with or without paclitaxel 80 mg/m(2) per week. We 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.

Results

We enrolled 39 evaluable patients. The single-agent cetuximab arm cl

SUBMITTER: Wong YN 

PROVIDER: S-EPMC3454772 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature