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• W2247131005 abstract "A19 Background
 We performed a Phase I/II trial of combination sorafenib (S) and bevacizumab (B) to inhibit the vascular endothelial growth factor (VEGF) pathway at the level of both ligand and receptor as well as platelet derived growth factor receptor β (PDGFR) signaling in patients (pts) with metastatic renal cell cancer (mRCC).
 Methods
 Patients with measurable mRCC, adequate organ function, and PS 0-1 were eligible. Cohorts of 6 pts were enrolled at 3 sites to define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combination. B was administered IV q 14 days (Q2W) and S by mouth daily (PO) on 28 day cycles. Response and toxicity were assessed at the end of 2 cycles. Dosing began with S at 200mg PO BID and B at 5 mg/kg Q2W (level I) and doses for subsequent cohorts were modified according to observed toxicities. High dose pyridoxine was administered in some later cohorts in an attempt to ameliorate toxicities.
 Results
 Demographics: A total of 48 pts were enrolled in the phase I trial, with all completing their first response evaluation. Median age: 61 years (range: 35-83); M/F: 40/8; PS: 0/1= 32/16; 41 clear cell, 3 papillary, 2 chromophobe, 2 sarcomatoid, 41 had prior nephrectomy; 6 prior IFN and 9 prior IL-2.
 Toxicity/DLT/MTD/RPTD: Dose-limiting toxicities consisted of grade 3 hand-foot syndrome, grade 3 anorexia, grade 3 decreased performance status and grade 3 hypertension. Additional toxicities included weight loss, stomatitis, gastroesophageal reflux, peptic ulcer, proteinuria, rash and fatigue. Dose levels -I (B 3mg/kg S 200 mg QD) and IA (B 5 mg/kg, S 200 mg QD) were well tolerated by all 12 pts. Dose level IA (B 5 mg/kg, S 200 mg QD) was well tolerated by all six pts for multiple cycles and was thus recommended as the MTD/RPTD. The addition of pyridoxine did not protect from toxicity.
 Antitumor effects: 46/48 pts were evaluable for response. 21 of 46 (46%) had RECIST defined PR, including both patients with sarcomatoid RCC. An additional 23 pts had SD, 1 developed PD and 1 died from disease progression prior to initial evaluation. 41/46 (89%) pts experienced some tumor shrinkage ranging from 5 - 80% from baseline.
 Conclusions
 B plus S has impressive antitumor activity in mRCC and can be administered safely at doses of B 5 mg/kg q 2 wks and S 200 mg QD. B appears to increase known S-related toxicities, especially HFS, anorexia, hypertension and fatigue. Late onset GERD/peptic ulcer emerged as a novel toxicity in several patients. Despite these toxicities, patients treated at the MTD were able to receive multiple cycles of therapy with no dose reductions. Only 4/48 patients overall discontinued therapy due to toxicities. We recently opened a Phase II trial of this regimen, which will incorporate PK studies for S to help determine the mechanism underlying apparent enhancement of S-related toxicity. In addition, this combination will be taken forward into an ECOG-sponsored, multi-arm Phase II trial (BEST trial) of combination regimens.
 Supported by U01 CA099177 and CTEP-NCI." @default.
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• W2247131005 date "2007-11-01" @default.
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• W2247131005 title "Final results of a phase I trial of sorafenib and bevacizumab in patients with metastatic renal cell cancer (mRCC)." @default.
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