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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of carboplatin and paclitaxel by making tumor cells more sensitive to the drugs.
PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and paclitaxel with oblimersen in treating patients who have advanced solid tumors.
- Determine the maximum tolerated dose of oblimersen when administered in combination with carboplatin and paclitaxel in patients with advanced solid tumors.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study of oblimersen.
Patients receive oblimersen IV continuously on days 1-7 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
An additional cohort of 12-15 patients receives treatment as above with oblimersen at the MTD.
PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study within 1 year.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
oblimersen sodium, carboplatin, paclitaxel
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:55:28-0400
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