Irinotecan Followed by Fluorouracil in Treating Patients With Advanced Solid Tumors

Roswell Park Cancer Institute

Overview

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of irinotecan followed by fluorouracil in treating patients who have advanced solid tumors.

OBJECTIVES: * Determine the optimal dose of irinotecan when administered before fluorouracil in patients with advanced solid tumors. * Determine the toxic effects of this regimen in these patients. * Correlate the pharmacokinetics of irinotecan with its biologic effects in these patients. * Assess, in a preliminary manner, the antitumor activity of this regimen in these patients. OUTLINE: This is a dose de-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and fluorouracil IV over 5 minutes on days 2, 9, 16, and 23. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive decreasing doses of irinotecan until the optimal dose is determined. The optimal dose is defined as the dose at which at least 3 of 6 patients show evidence of recruitment of cells into the S phase at 24 hours after irinotecan administration. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 12-18 months.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

fluorouracilDRUG

irinotecan hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven recurrent or metastatic solid tumor that is not amenable to curative surgery, radiotherapy, or conventional chemotherapy of proven value * Must have disease that can be safely and readily biopsied under local anesthesia (including, but not limited to, subcutaneous metastases, superficial lymph node metastases, or ascites) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST less than 2 times ULN * Alkaline phosphatase less than 2 times ULN * Lactic dehydrogenase less than 2 times ULN Renal: * Creatinine no greater than 1.5 times ULN Other: * HIV negative * No active uncontrolled bacterial, viral, or fungal infection * No nonmalignant systemic disease that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * No prior irinotecan Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy except small-port radiotherapy for local control * No concurrent radiotherapy except small-port radiotherapy for local disease control (e.g., pain relief or impending fracture) Surgery: * See Disease Characteristics * At least 2 weeks since prior major surgery Other: * No concurrent anticoagulants except warfarin or subcutaneous heparin

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Data from ClinicalTrials.gov

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