A Phase I Trial of ZD1839 With Capecitabine in Patients With Advanced Solid Tumors (Formerly a Phase I Trial of ZD1839 With Capecitabine and Celecoxib)
I. Determine the maximum tolerated dose of gefitinib and capecitabine in patients with
advanced solid tumors.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
III. Determine the pharmacologic profile of this regimen in these patients.
OUTLINE: This is a dose-escalation study of gefitinib and capecitabine.
Patients receive oral gefitinib once daily on days 1-14 and oral capecitabine twice daily on
days 8-21. Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gefitinib and
capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 11-41 patients will be accrued for this study within 2.5
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) defined as the those below that results in dose-limiting toxicity (DLT) in >= 2 of 6 new patients, as assessed by CTCAE version 3.0
University of Colorado, Denver
United States: Food and Drug Administration
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