Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of Oblimersen (Genasense™, G3139) in Combination With Gemcitabine in Advanced Malignancies
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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