Flavopiridol in Treating Patients With Refractory Cancer

Phase 1

Completed

• Conditions: Lymphoma; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Small Intestine Cancer

• Registration Number: NCT00019344
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Study Timeline

• Study Start: 1997-08
• Study First Submitted: 2001-07-11
• Status Verified: 2002-05
• Study First Submitted QC: 2004-04-20
• Study First Posted: 2004-04-21
• Last Update Submitted: 2015-04-28
• Last Update Posted: 2015-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Medicine Branch; 🇺🇸 Bethesda, Maryland, United States