Phase I study of sunitinib in combination with gemcitabine and capecitabine for first-line treatment of metastatic or unresectable renal cell carcinoma.

ABSTRACT:

Background

The combination of gemcitabine plus capecitabine and sunitinib (GCS) shows activity in metastatic renal cell carcinoma (mRCC). We tested the multitargeted "chemo-switch" regimen as first-line treatment in patients with mRCC.

Methods

We assessed the maximum tolerated dose and antitumor activity of GCS in treatment-naïve, advanced mRCC patients. Treatment consisted of intravenous gemcitabine on days 1 and 8, oral capecitabine twice daily on days 1-14, and oral sunitinib daily for six 21-day cycles, followed by sunitinib monotherapy at the investigator's discretion. Dose level 0 (DL0) was gemcitabine 1,000 mg/m(2) per day plus capecitabine 650 mg/m(2) per 12 hours plus sunitinib 37.5 mg/day; DL1 was gemcitabine 1,000 mg/m(2) per day plus capecitabine 850 mg/m(2) per

SUBMITTER: Bellmunt J 

PROVIDER: S-EPMC4153461 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature