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• W2527834066 abstract "e14055 Background: Given limits of individual targeted therapies in the treatment of mCRC, combining agents is increasingly attractive. ZD6474 is an orally bioavailable inhibitor of VEGFR-2 and EGFR tyrosine kinases. Methods: Phase I trial with cetuximab, irinotecan, and ZD6474 in previously treated patients with mCRC (initiated March 2007 but amended August 2008 to limit to KRAS wild type after first 7 pts). Standard phase I design of 3 pts/dose level with expansion of 3 more pts if DLT observed; 2 DLTs defined maximum tolerated dose (MTD) as dose level -1 (dose levels 1 and 3 required pt replacements). After a loading dose, 250 mg/m2 of cetuximab was administered weekly. Irinotecan was 180 mg/m2 every other week. Oral ZD6474 was tested at 100 mg, 200 mg, and 300 mg daily. Dose level 1 did not include irinotecan. Ten patients will be tested at the MTD. Results: Between March 2007 and December 2009, 24 patients were enrolled at 4 dose levels and at the MTD (Table). Median age = 53; male: female = 11:13. 56% had prior irinotecan; 78% prior oxaliplatin. KRAS status: 17 wild type, 2 mutant, and 5 unknown. The MTD was determined to be 200 mg ZD6474 daily. Of 21 evaluable (2 withdrew prior to staging; 1 not staged to date), 10% partial response, 62% stable disease (SD), and 18% progressed. Of those with SD, 38% had at least 20% shrinkage. Median progression-free survival (PFS) is 3.9 months (m) (95% CI, 3.5-5.7) and median overall survival (OS) is 13.5 m (95% CI, 4.8-20.6) in all patients; PFS is 4.9 m (95% CI, 3.5-11.7) and OS is not reached when limited to KRAS wildtype. Grade 3/4 toxicities occurring in more than 1 patient: grade 3 diarrhea 29%, grade 3 electrolyte change 21%, grade 3 neutropenia 13%, grade 3 abdominal/pelvis pain 8%, grade 3 rash 8% and grade 3 renal dysfunction due to dehydration 8%. Conclusions: ZD6474 at 200 mg daily can be combined with cetuximab and irinotecan for mCRC. The trial is ongoing and updated efficacy and safety will be available for June 2010. Dose level # of pts ZD6474 Cetuximab Irinotecan DLTs 1 4 100 mg X – None 2 3 100 mg X X None 3 5 200 mg X X None 4 5 300 mg X X * Grade 3 QTc prolongation (n=1)* Grade 3 diarrhea (n=1) MTD 7 200 mg X X Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, Bristol-Myers Squibb, sanofi-aventis Bristol-Myers Squibb" @default.
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• W2527834066 date "2010-05-20" @default.
• W2527834066 modified "2023-09-25" @default.
• W2527834066 title "Phase I study of cetuximab, irinotecan, and vandetanib (ZD6474) in previously treated metastatic colorectal cancer (mCRC)." @default.
• W2527834066 doi "https://doi.org/10.1200/jco.2010.28.15_suppl.e14055" @default.
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