NCT00042874|CompletedPhase 1

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

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

National Cancer Institute (NCI)ClinicalTrials.gov

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6 other identifiers

NCI-2012-014105757NCI-5757CDR0000069479MSKCC-02024U01CA069856

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2003

StartedMay 2002

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2002

Completed

6 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed

Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

6.7 years

First QC Date

August 5, 2002

Last Update Submit

June 3, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

MTD of biweekly flavopiridol when given in conjunction with irinotecan hydrochloride, fluorouracil, and leucovorin
8 weeks

Secondary Outcomes (3)

Clinical pharmacokinetics of the regimen under investigation
Day 1, prior to flavopiridol infusion (t=3:30hr), post flavopiridol infusion (t=4:30hr), prior to flavopiridol infusion (t=3:30hr), post 30 minute flavopiridol bolus (t=4:00), post 4 hour flavopiridol infusion (t=8:00hr)
Therapeutic activity of flavopiridol in combination with irinotecan hydrochloride in patients with advanced solid tumors
Up to 7 years
Change in molecular marker expression
Baseline to 2 weeks post-treatment

Study Arms (1)

Treatment (combination chemotherapy)

EXPERIMENTAL

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.

Drug: alvocidibDrug: irinotecan hydrochlorideDrug: fluorouracilDrug: leucovorin calciumOther: laboratory biomarker analysis