Breast Cancer Clinical Trial
Official title:
Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining irinotecan and gemcitabine in
treating patients who have unresectable or metastatic solid tumors.
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) and the principal toxicities of irinotecan
and gemcitabine in patients with surgically unresectable or metastatic solid tumors.
- Determine if the principal toxicities and MTD of this combination regimen are affected
by drug sequencing in this patient population.
- Determine the potential for gemcitabine to alter the pharmacokinetic characteristics
when administered with irinotecan in these patients.
- Describe the influence effected by varying the administration sequence of this
combination regimen in this patient population.
- Obtain preliminary data regarding efficacy of this combination regimen in these
patients.
OUTLINE: This is a dose-escalation study.
Patients receive irinotecan IV over 90 minutes followed by gemcitabine IV over 30 minutes on
days 1 and 15. Treatment repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity. Once the maximum tolerated dose (MTD) is reached, patients receive
subsequent doses of the inverse sequence of the combination drugs until a new MTD is
determined.
Cohorts of 3-6 patients receive escalating doses of irinotecan and gemcitabine until the MTD
is reached. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients
experience dose limiting toxicities.
Patients are followed every 3 months until death.
PROJECTED ACCRUAL: At least 12 patients will be accrued for this study.
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