A phase II study of first-line biweekly capecitabine and bevacizumab in elderly patients with metastatic colorectal cancer.

Purpose: This phase II study was conducted to determine the efficacy and safety of capecitabine and bevacizumab in untreated elderly metastatic colorectal cancer patients.
Methods: Patients received 1500 mg/m(2)/dose of capecitabine twice daily x 7 days and bevacizumab at 5mg/kg on day 1, in 2 week-cycles.
Results: The study was closed early, due to poor accrual, after a total of 16 patients enrolled. Four patients had an objective response and 11 patients had stable disease. The median time to progression and overall survival were 9.5 and 21.2 months, respectively. The most common grade >or= 3 toxicities included diarrhea (13%) and hand and foot syndrome (25%). Three patients had an arterial thrombotic event and one patient developed a bowel perforation.
Conclusions: In this underpowered phase II study in elderly patients with metastatic colorectal cancer, capecitabine plus bevacizumab was associated with considerable clinical activity but at an increased risk of hand and foot syndrome and arterial thrombotic events.