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• W2227199615 abstract "5085 Background: Liposomal Doxorubicin has activity in both breast and ovarian cancer. Preclinical data reported by several investigators have suggested that ZD1839 acts synergistically with chemotherapy in ovarian cancer cells expressing high levels of EGFR. Given the lack of cross resistance and the different targets for these agents a Phase I trial was initiated examining the safety and the efficacy of the combination of Liposomal Doxorubicin and ZD1839. Methods: Dose limiting toxicity was defined within the first two cycles of treatment. The dose escalation schema was described as such: Results: As of January 2006, 23 patients have been enrolled in this study (GYN = 6; Breast 17). Six patients were enrolled in dose level 1 and no DLTs were observed. Dose level 2 enrolled six patients. One DLT was observed (febrile neutropenia). As defined by protocol an additional 6 patients were accrued to dose level 2. Accrual to dose level 3 began on 11/2005. One patient has completed 2 cycles and no additional DLTs have been noted. MTD has not yet been reached. SAEs have included mental status changes, and two CNS bleeds (believed most likely to be unrelated to study drug combination). Toxicities noted in cycle 3 and above have been mild with the exception of 2 grade 3 and 2 grade 4 toxicities related to skin and GI toxicity. No cardiac toxicity was observed. Doxil dose modifications (cycle 3 +) occurred in 7 patients. Best response to therapy has included 2 PRs and 10 patients with SD. Eleven patients to date have had progressive disease. The trial continues to accrue. Correlative studies including EGFR expression and CECs and PKs (at MTD) are planned. Conclusion: Liposomal Doxorubicin in conjunction with ZD1839 is tolerable regimen in patients with advanced breast and ovarian cancer. To date MTD has not been reached. [Table: see text] [Table: see text]" @default.
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• W2227199615 date "2006-06-20" @default.
• W2227199615 modified "2023-10-14" @default.
• W2227199615 title "Phase I trial of liposomal doxorubicin and ZD 1839 in patients with refractory gynecological malignancies or metastatic breast cancer" @default.
• W2227199615 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.5085" @default.
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