Last updated on January 2011

FR901228 and Flavopiridol in Treating Patients With Advanced Lung Esophageal or Pleural Cancer


Brief description of study

RATIONALE: Drugs used in chemotherapy, such as FR901228 and flavopiridol, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving FR901228 together with flavopiridol may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of FR901228 when given together with flavopiridol in treating patients with advanced lung, esophageal, or pleural cancer.

Detailed Study Description

OBJECTIVES: Primary - Determine the maximum tolerated dose and dose-limiting toxic effects of FR901228 (depsipeptide) when administered with flavopiridol in patients with advanced primary lung or esophageal cancer, malignant pleural mesothelioma, or lung or pleural metastases. - Determine the pharmacokinetics of this regimen in these patients. Secondary - Analyze gene expression in laser-captured tumor cells, buccal mucosa, and peripheral blood mononuclear cells of these patients before and after treatment with this regimen. - Analyze mcl-1 protein expression and apoptosis in tumor biopsies from these patients before and after treatment with this regimen. OUTLINE: This is a dose-escalation study of FR901228 (depsipeptide). Patients receive FR901228 IV over 4 hours followed by flavopiridol IV continuously over 72 hours beginning on days 1 and 15. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of FR901228 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. Six additional patients receive treatment at the MTD. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 1-2 years.

Clinical Study Identifier: NCT00098644

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Recruitment Status: Open


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