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Crossover Evaluation of Effect of Atorvastatin on PK of Irinotecan in CRC Patients Receiving FOLFIRI

NCT01605344 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-02-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetic profile of irinotecan and SN-38. To further evaluate the safety of atorvastatin in combination with FOLFIRI. To further evaluate the safety and of irinotecan in combination with atorvastatin.

Conditions

  • Advanced Adenocarcinoma of the Colon or Rectum

Interventions

DRUG

FOLFIRI.

All patients will receive FOLFIRI infusion on day 1 and day 15.

DRUG

Atorvastatin

A subjects will receive atorvastatin 20 mg orally once daily given for two weeks starting on Day -14 during PERIOD ONE. ARM A will then receive no statin during PERIOD TWO. ARM B subjects will receive no atorvastatin during PERIOD ONE. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks during PERIOD TWO (starting on Day 2). One cycle = 28 days.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Autumn McRee, MD · University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01605344 on ClinicalTrials.gov