Drugs used in chemotherapy such as gemcitabine use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of gemcitabine by making cancer cells more sensitive to the drug. This phase I trial is studying the side effects and best dose of oblimersen and gemcitabine in treating patients with metastatic or unresectable solid tumors or lymphoma
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of oblimersen and gemcitabine in patients with advanced solid tumor or lymphoma. II. Determine the effect of oblimersen on the pharmacokinetics and pharmacodynamics of gemcitabine in these patients. III. Determine the toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients receive treatment at the MTD. PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 6-8 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Stanford University
Stanford, California, United States
MTD defined as the dose level at which less than 2 out of 6 patients experience DLT assessed using NCI CTC version 2.0
Descriptive statistics will be employed in the analysis of all safety and laboratory observations.
Time frame: 4 weeks
Pharmacokinetics
Peak concentration and area under the concentration time curves of gemcitabine triphosphate will be will be utilized to assess the pharmacodynamic relationship of gemcitabine triphosphate concentration to bivariate toxicity and tumor responses using logistic regression analysis.
Time frame: Pre-dose, 4, 8, 12, 24, 48, 72, 96, 120, 121.67, 126, and 129 hours
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