Spots Global Cancer Trial Database for Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

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Trial Identification

Brief Title: Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Official Title: An Open-Labeled, Non-Randomized Phase I Study of Alvocidib (Flavopiridol) Administered With Irinotecan (CPT-11) and Fluorouracil/Leucovorin in Patients With Advanced Solid Tumors

Study ID: NCT00042874

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

alvocidib

irinotecan hydrochloride

fluorouracil

leucovorin calcium

laboratory biomarker analysis

Study Description

Brief Summary: 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. This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with locally advanced or metastatic solid tumors.

Detailed Description: PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of flavopiridol (alvocidib) when administered with irinotecan hydrochloride, fluorouracil, and leucovorin calcium in patients with locally advanced or metastatic solid tumors. II. Determine the clinical pharmacokinetics of fluorouracil when administered in this regimen in these patients. III. Determine, preliminarily, the therapeutic activity of this regimen in these patients.Correlate the role of p21 and Drg1 with apoptosis and treatment response in patients receiving this regimen. OUTLINE: This is a dose-escalation study of alvocidib and fluorouracil (5-FU). Patients receive irinotecan hydrochloride IV over 90 minutes followed 5 hours later by leucovorin calcium IV over 2 hours and alvocidib IV over 1 hour immediately followed by 5-FU IV continuously over 48 hours beginning on day 1 of weeks 1, 3, and 5. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of alvocidib and 5-FU 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. Ten additional patients are treated at the MTD. PROJECTED ACCRUAL: A total of 27-77 patients will be accrued for this study within 11-38 months.