Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when combined with
docetaxel in patients with advanced solid malignancies. II. Determine the dose limiting
toxicity of this regimen in these patients. III. Assess any antitumor activity of this
regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study of irinotecan. Patients receive
docetaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes on days 1, 8,
15, and 22. Treatment continues every 6 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every
3 months for 1 year, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study.
Primary Purpose: Treatment
John R. Murren, MD
United States: Federal Government
|Yale Comprehensive Cancer Center||New Haven, Connecticut 06520-8028|
|Bennett Cancer Center||Stamford, Connecticut 06902|