TY - JOUR
T1 - A phase II study of everolimus in combination with imatinib for previously treated advanced renal carcinoma
AU - Ryan, Christopher W.
AU - Vuky, Jacqueline
AU - Chan, Joseph S.
AU - Chen, Zunqiu
AU - Beer, Tomasz M.
AU - Nauman, Deirdre
N1 - Funding Information:
Acknowledgments This investigation was supported in part by funding from Novartis and NIH/NCI Cancer Center Support Grant (P30 CA069533).
PY - 2011/4
Y1 - 2011/4
N2 - Purpose: This phase II study evaluated the activity of combined treatment with the mTOR inhibitor everolimus and the PDGFR inhibitor imatinib in patients with previously-treated, advanced renal carcinoma. The primary endpoint was estimation of the 3-month progression-free rate. Patients and methods: Eligible patients had metastatic or unresectable clear cell renal carcinoma, at least one prior systemic therapy, no prior mTOR inhibitor therapy, performance status 0-2, and measurable disease. Treatment consisted of everolimus 2.5 mg p.o. daily and imatinib 600 mg p.o. daily. The primary endpoint was the 3-month progression-free rate. Results: The study was closed after the first 19 patients because of an insufficient number of patients who were progression-free at 3 months. The 3-month progression-free rate was 49% (95% C.I. 23%, 72%) and the median progression-free survival was 2.9 months (95% C.I. 1.9, 6.2). Toxicities with an incidence of >50% included nausea, elevated serum creatinine, edema, anemia, hypocalcemia, fatigue, diarrhea, vomiting, and dyspnea, and leukopenia. Conclusion: The combination of everolimus with imatinib in previously treated patients with advanced renal carcinoma did not result in a sufficient 3-month progression-free rate to warrant further investigation of this combination.
AB - Purpose: This phase II study evaluated the activity of combined treatment with the mTOR inhibitor everolimus and the PDGFR inhibitor imatinib in patients with previously-treated, advanced renal carcinoma. The primary endpoint was estimation of the 3-month progression-free rate. Patients and methods: Eligible patients had metastatic or unresectable clear cell renal carcinoma, at least one prior systemic therapy, no prior mTOR inhibitor therapy, performance status 0-2, and measurable disease. Treatment consisted of everolimus 2.5 mg p.o. daily and imatinib 600 mg p.o. daily. The primary endpoint was the 3-month progression-free rate. Results: The study was closed after the first 19 patients because of an insufficient number of patients who were progression-free at 3 months. The 3-month progression-free rate was 49% (95% C.I. 23%, 72%) and the median progression-free survival was 2.9 months (95% C.I. 1.9, 6.2). Toxicities with an incidence of >50% included nausea, elevated serum creatinine, edema, anemia, hypocalcemia, fatigue, diarrhea, vomiting, and dyspnea, and leukopenia. Conclusion: The combination of everolimus with imatinib in previously treated patients with advanced renal carcinoma did not result in a sufficient 3-month progression-free rate to warrant further investigation of this combination.
KW - Everolimus
KW - Imatinib
KW - Phase II clinical trial
KW - Renal cell carcinoma
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U2 - 10.1007/s10637-009-9365-y
DO - 10.1007/s10637-009-9365-y
M3 - Article
C2 - 20012337
AN - SCOPUS:79957552225
SN - 0167-6997
VL - 29
SP - 374
EP - 379
JO - Investigational New Drugs
JF - Investigational New Drugs
IS - 2
ER -