S0312, Gemcitabine and Capecitabine in Treating Patients With Advanced Renal Cell (Kidney) Cancer

Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine and capecitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced renal cell cancer (kidney cancer).

Timeline

Start

2004-12

Primary completion

2007-05

Completion

2008-11

Outcome

Met primary endpoint

paper There was 1 complete response and 3 partial responses, for an overall RR of 10% (95% CI = 3, 24). PMID 19487915 ↗

Publications

• Results Van Veldhuizen PJ, Hussey M, Lara PN Jr, Mack PC, Gandour-Edwards R, Clark JI, Lange MK, Crawford DE. A phase ii study of gemcitabine and capecitabine in patients with advanced renal cell cancer: Southwest Oncology Group Study S0312. Am J Clin Oncol. 2009 Oct;32(5):453-9. doi: 10.1097/COC.0b013e3181925176.
• Results van Veldhuizen PJ, Hussey M, Lara PN, et al.: A phase II study of IV gemcitabine (G) and oral capecitabine (C) in patients (pts) with advanced renal cell cancer (RCC): results of Southwest Oncology Group study 0312. [Abstract] J Clin Oncol 25 (Suppl 18): A-15562, 654s, 2007.

Drugs

Indications