NCT00138060

Brief Summary

This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration. The results of this identification determine the chemotherapy type: high-dose irinotecan or not.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

3.4 years

First QC Date

August 26, 2005

Last Update Submit

July 19, 2010

Conditions

Metastatic Colorectal Cancer

Keywords

genotypic profilemetastatic colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • tumor response rate

    during the treatment

Secondary Outcomes (2)

  • toxicity

    during the treatment

  • pharmacokinetics

    during the first administration

Interventions

irinotecanDRUG

180 mg/m² or 260 mg/m² in 90 minutes every 15 days

5 fluorouracilDRUG

400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice
  • Ages between 18 and 85 years
  • Histologically confirmed colorectal cancer
  • No treatment for metastatic disease
  • No irinotecan previously administered
  • World Health Organization (WHO) performance status \< 3
  • Laboratory values :
  • neutrophils \> 1.5 x 10\^9/L;
  • platelet count \> 100 x 10\^9/L;
  • serum creatinine \< 130µmol/L;
  • serum bilirubin \< 2 x upper limit of normal (ULN);
  • ASAT and ALAT \< 2.5 x ULN;
  • alkaline phosphatase \< 5 x ULN.
  • At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

You may not qualify if:

  • History of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder.
  • Other concomitant anticancer therapy.
  • Pregnant or lactating women.
  • Women of childbearing potential unless using a reliable and appropriate contraceptive method.
  • Symptomatic cerebral or leptospiral metastasis.
  • Intestinal obstruction.
  • Uncontrolled seizures (diabetes, severe infection).
  • Clinically significant cardiac disease.
  • Central nervous system disorders or severe psychiatric disability.
  • Participation in any investigational study within 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Oncology, CHU

Grenoble, 38043, France

Location

Department of Oncology, IPC

Grenoble, 38100, France

Location

Department of Gastroenterology, CHLS

Pierre-Bénite, 69310, France

Location

Department of Oncology - CHLS

Pierre-Bénite, 69310, France

Location

Department of Oncology, ICL

Saint-Priest-en-Jarez, 42271, France

Location

Institut Claudius Regaud

Toulouse, France

Location

Related Publications (1)

  • Iyer L, Das S, Janisch L, Wen M, Ramirez J, Karrison T, Fleming GF, Vokes EE, Schilsky RL, Ratain MJ. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J. 2002;2(1):43-7. doi: 10.1038/sj.tpj.6500072.

    PMID: 11990381BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IrinotecanFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Gilles Freyer, MD

    Department of Oncology, CHLS, 69310 Pierre Benite, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

June 1, 2005

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

July 20, 2010

Record last verified: 2010-07

Locations

FR(6)