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- W4231524910 abstract "3580 Background: Erlotinib (Tarceva) is an orally active, selective inhibitor of the HER1/EGFR tyrosine kinase with clinical activity in various solid tumors. The combination of capecitabine (C) and oxaliplatin (O) is becoming an increasingly attractive option to use in the treatment of MCRC. We conducted a phase II study to evaluate the objective response rate (ORR) of O+C+erlotinib in previously treated patients (pts) with MCRC. Methods: Eligible pts had measurable MCRC, either 1 prior systemic regimen for MCRC or progression of disease within 12 months of adjuvant therapy, performance status 0–2. The treatment regimen consisted of 21-day cycles of C at 1000 mg/m2 BID x 14 days (reduced to 750 mg/m2 after first 13 patients experienced excess of grade (gr) 3/4 toxicities), O at 130 mg/m2 on day 1, and erlotinib 150 mg qd. Responses were based on RECIST criteria Results: To date, 22 pts have been enrolled with the following characteristics: male/female, 16/6; PS ECOG 0/1, 11/11; median age 59, range 32–73; 73% prior CPT-11 for metastatic disease. 20 patients are evaluable for response and 22 patients are evaluable for toxicity. The ORR was 20 % (0 CR, 4 PR [2 confirmed, 2 unconfirmed]). 64% of patients had stable disease (8 pts > 4 months). Prior to the dose reduction of C, 11 of 13 pts had grade 3/4 toxicities (primarily GI toxicities). Since the dose reduction of C (9 pts), there have only been 4 pts with gr 3/4 toxicities and no pts off study due to toxicity. Based on the current enrollment rate, we expect full accrual of 32 pts and updated results (including ORR and time-to-progression) by June 2004. Conclusions: In a population of previously treated patients with MCRC, capecitabine, oxaliplatin and erlotinib appears to be an active regimen. Initial toxicities of the regimen have been markedly improved upon with a modest dose reduction. Supported by: Sanofi-Synthelabo, Roche Laboratories, Genentech. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb Sanofi-Synthelabo" @default.
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- W4231524910 date "2004-07-15" @default.
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- W4231524910 title "Phase II study of capecitabine, oxaliplatin and erlotinib in previously treated patients with metastatic colorectal cancer (MCRC)" @default.
- W4231524910 doi "https://doi.org/10.1200/jco.2004.22.90140.3580" @default.
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