NCT00320320

Brief Summary

The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

April 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

November 25, 2008

Status Verified

November 1, 2008

Enrollment Period

2 years

First QC Date

May 1, 2006

Last Update Submit

November 24, 2008

Conditions

Colorectal NeoplasmsMetastases

Keywords

No prior chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Response rate after FOLFIRI reintroduction

Secondary Outcomes (2)

  • Progression-free survival

  • Overall survival

Interventions

IrinotecanDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven adenocarcinoma of colon and rectum
  • No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy
  • Advanced, metastatic or recurrent not amenable to curative local therapy
  • Measurable lesion(s)
  • ECOG performance status 0 to 2
  • Normal marrow, hepatic and renal function
  • Provision of written informed consent

You may not qualify if:

  • Active infection and/or severe comorbidity
  • Known history of anaphylaxis of any origin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405 760, South Korea

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

Irinotecan

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)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Se Hoon Park, MD

    Gachon University Gil Medical Center, Incheon, Korea

    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

May 1, 2006

First Posted

May 3, 2006

Study Start

April 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

November 25, 2008

Record last verified: 2008-11

Locations

KR(1)