Irinotecan and Gemcitabine in Treating Patients With Refractory 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with gemcitabine in treating patients who have refractory advanced solid tumors.

OBJECTIVES: * Determine the maximum tolerated dose of irinotecan when administered with gemcitabine in patients with refractory advanced solid tumors. * Determine the antitumor activity and toxicity of this regimen in these patients. * Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients. * Determine the optimal dose and time interval for this regimen in these patients. OUTLINE: This is an open-label, non-randomized, dose-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days 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 8 weeks. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

gemcitabine hydrochlorideDRUG

irinotecan hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced solid tumor that is refractory to prior treatment * Considered incurable with other modalities * Measurable or evaluable disease * The following are not considered measurable or evaluable: * Bone metastases * Pleural, pericardial, or peritoneal effusions * Irradiated lesions (unless progression is documented after radiotherapy) * Metastatic disease that has been followed using serum tumor markers allowed * No symptomatic brain metastases * Brain metastases may not be sole site of metastatic disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * At least 12 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * AST and ALT no greater than 1.5 times normal * Bilirubin no greater than 1.5 mg/dL * No clinically apparent jaundice Renal * Creatinine no greater than 1.6 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular * Cardiac function normal * No uncontrolled heart disease * No myocardial infarction within the past 3 months * No congestive heart failure * No unstable or uncontrolled angina Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No active infection requiring systemic therapy * No uncontrolled seizures * No uncontrolled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior gemcitabine * No prior camptothecin compounds * Prior irinotecan allowed * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 14 days since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 30 days since prior clinical trial participation * No other concurrent investigational medications

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Data from ClinicalTrials.gov

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