A Phase I and Pharmacokinetics Study of Docetaxel in Combination With Capecitabine and Cisplatin in Solid Tumors
- Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in
patients with advanced solid tumors.
- Determine the dose-limiting toxicity and recommended phase II dose of this regimen in
- Determine the non-dose-limiting toxic effects associated with this regimen in these
- Determine the pharmacokinetics of this regimen in these patients.
- Determine any clinical activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 30 minutes and cisplatin IV over 30 minutes on days 1 and
8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel, cisplatin, and capecitabine
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At
least 6 patients receive treatment at the MTD.
PROJECTED ACCRUAL: A minimum of 21 patients will be accrued for this study within 1.5 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the maximum tolerated dose of docetaxel, cisplatin, and capecitabine in patients with advanced solid tumors.
Every 21 days
Marwan Fakih, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|