Phase I Trial of Irinotecan (CPT-11) and Gemcitabine in Patients With Solid Tumors
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:
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.
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic or surgically unresectable solid tumor, having received the following maximum number of prior therapies for advanced disease:
Bidimensionally measurable disease outside a previously irradiated field
No known bone metastases
CNS involvement allowed if successfully controlled by surgery or radiotherapy and not requiring corticosteroids
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: