NCT00544349

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and giving them together with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving leucovorin together with fluorouracil, cetuximab, and oxaliplatin works in treating patients with stage IV colorectal cancer and liver metastases that cannot be removed by surgery.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 colorectal-cancer

Geographic Reach
1 country

7 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

October 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

May 17, 2011

Status Verified

July 1, 2009

Enrollment Period

4.6 years

First QC Date

October 13, 2007

Last Update Submit

May 14, 2011

Conditions

Colorectal CancerMetastatic Cancer

Keywords

stage IV colon cancerrecurrent colon cancerstage IV rectal cancerrecurrent rectal cancerliver metastases

Outcome Measures

Primary Outcomes (1)

  • Efficacy: objective tumor response rate (RECIST criteria)

Secondary Outcomes (7)

  • Toxicity as assessed by NCI CTCAE v3.0

  • Duration of response

  • Duration and rate of tumor control

  • Secondary resectability of hepatic metastases

  • Progression-free survival

  • +2 more secondary outcomes

Interventions

cetuximabBIOLOGICAL
fluorouracilDRUG
leucovorin calciumDRUG
oxaliplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • WHO performance status 0-1
  • Life expectancy \> 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Creatinine ≤ 1.5 times normal
  • Bilirubin ≤ 1.5 times upper limit of normal
  • Transaminases ≤ 5 times normal
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

You may not qualify if:

  • Contraindication or allergy grade 3-4 to any components of the study drugs
  • Peripheral neuropathy
  • Intestinal occlusion or subocclusion or prior inflammatory intestinal disease
  • Severe cardiac disease including any of the following:
  • Symptomatic coronary disease
  • Myocardial infarction in the past 6 months
  • New York Heart Association grade II-IV cardiac insufficiency
  • Severe arrhythmia (even if treated)
  • Active or uncontrolled infection
  • Other concurrent serious disorder
  • Severe uncontrolled medical condition
  • Other malignancy within the past 5 years or concurrently except basal cell skin cancer or carcinoma in situ of the cervix
  • Study impossible due to psychological, geographical, or social reasons
  • Prisoners or patients under guardianship
  • PRIOR CONCURRENT THERAPY:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hopital Saint Andre

Bordeaux, 33075, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Centre Eugene Marquis

Rennes, 35062, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms

Interventions

CetuximabFluorouracilLeucovorinOxaliplatin

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)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Officials

  • David Malka, MD, PhD

    Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2007

First Posted

October 16, 2007

Study Start

October 1, 2006

Primary Completion

May 1, 2011

Last Updated

May 17, 2011

Record last verified: 2009-07

Locations

FR(7)