TITLE: AXITINIB as second-line therapy for metastatic renal cell cancer: Axis trial
PROTOCOL ID: AG 013736, NCT00678392
CONTACT: Pfizer Oncology Clinical Trial, Information Service, 1-877-369-9753; or PfizerCancerTrials@emergingmed.com
SUMMARY: This phase 3 interventional study is designed to demonstrate that axitinib is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of 1 first-line regimen. Axitinib will be given at a starting dose of 5 mg twice daily with continuous dosing. Sorafenib also will be given twice daily at a dose of 400 mg, also with continuous dosing. The primary outcome measure will be progression-free survival after 3 years. A comparison of overall survival and response rates after 3 years, an evaluation of the safety and tolerability of axitinib, an estimation of the duration of response in each treatment arm, and a comparison of kidney-specific symptoms and health status will be secondary outcome measures. ELIGIBILITY: Patients must be aged 18 years or older and have histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype with metastasis, evidence of measurable disease, and 1 failed prior systemic first-line regimen for metastatic renal cell cancer. The patient must not have received prior treatment for metastatic renal cell cancer with more than 1 systemic first-line therapy or major surgery fewer than 4 weeks previously or radiotherapy within fewer than 2 weeks of the initiation of the study drug.