Flavopiridol in Treating Patients With Refractory Cancer
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|ClinicalTrials.gov Identifier: NCT00019344|
Recruitment Status : Completed
First Posted : April 21, 2004
Last Update Posted : April 29, 2015
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of flavopiridol in treating patients who have refractory cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Prostate Cancer Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: alvocidib||Phase 1|
OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of flavopiridol in patients with refractory solid tumors or lymphoma. 2. Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive flavopiridol IV over 1 hour on day 1. Treatment continues every 3 weeks in the absence of disease progression. A cohort of 3-6 patients receives treatment at each dose level of flavopiridol. If dose-limiting toxicity (DLT) occurs in no more than 1 of 6 patients, subsequent cohorts of 6 patients each receive escalating doses of drug on the same schedule. Intrapatient dose escalation to the next level is permitted in the absence of DLT.
PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study within 27 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms|
|Study Start Date :||August 1997|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019344
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Edward A. Sausville, MD, PhD||National Cancer Institute (NCI)|