NCT00313859

Brief Summary

This trial is designed to assess the tolerability and efficacy of simvastatin plus FOLFIRI (irinotecan, 5-FU, leucovorin) in metastatic colorectal cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2 colorectal-cancer

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

September 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

First QC Date

April 11, 2006

Last Update Submit

January 31, 2012

Conditions

Colorectal CancerMetastasis

Keywords

colorectal cancermetastatic

Outcome Measures

Primary Outcomes (1)

  • overall response rate

Secondary Outcomes (4)

  • progression-free survival

  • overall survival

  • toxicity

  • duration of response

Interventions

simvastatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed metastatic colorectal cancer
  • Age ≥ 18
  • ECOG performance status 0 - 2
  • At least one measurable lesion
  • Minimum life expectancy of 12 weeks
  • Adequate bone marrow reservoir (ANC ≥ 1500/㎕, platelet ≥ 100,000/㎕)
  • Adequate renal function (serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 min/ml)
  • Adequate liver functions (serum bilirubin ≤ 1.5 mg/dl, AST/ALT ≤ 3 times upper normal limits)
  • No prior lipid-lowering therapy with statins less than 1 year before study entry
  • No prior chemo- or immunotherapy for metastatic CRC (adjuvant chemotherapy or chemoradiation therapy more than 6 months before study entry is permitted)
  • Written informed consent

You may not qualify if:

  • Active infection requiring antibiotics therapy
  • Pregnancy and/or lactation
  • Other serious illness or medical condition not appropriate for chemotherapy, especially cardiovascular disease
  • Metastatic brain lesions
  • Receipt of radiotherapy within 2 weeks before the initiation of study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Won Ki Kang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 12, 2006

Study Start

September 1, 2005

Study Completion

August 1, 2007

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

KR(1)