Trials / Completed
CompletedNCT00019344
Flavopiridol in Treating Patients With Refractory Cancer
A Phase I Trial of Daily Bolus Flavopiridol for Five Consecutive Days in Patients With Refractory Neoplasms
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | alvocidib |
Timeline
- Start date
- 1997-08-01
- First posted
- 2004-04-21
- Last updated
- 2015-04-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00019344. Inclusion in this directory is not an endorsement.