NCT00066274

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells. PURPOSE: This randomized phase II trial is studying combination chemotherapy containing irinotecan and oxaliplatin to see how well it works compared to two standard combination chemotherapy regimens in treating patients with unresectable metastatic colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2002

Typical duration for phase_2 colorectal-cancer

Geographic Reach
1 country

17 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

July 23, 2002

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

August 6, 2003

Last Update Submit

February 25, 2021

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancer

Interventions

FOLFIRI regimenDRUG
FOLFOX regimenDRUG
fluorouracilDRUG
irinotecan hydrochlorideDRUG
leucovorin calciumDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal carcinoma * Metastatic disease * Not amenable to surgery * Unidimensionally measurable disease * No bone metastases * No brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * WHO 0-2 Life expectancy * At least 12 weeks Hematopoietic * Neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 1.25 times upper limit of normal (ULN) (1.5 times ULN if hepatic metastases are present) * SGPT and SGOT no greater than 3 times ULN (5 times ULN if hepatic metastases are present) Renal * Creatinine no greater than 1.25 times ULN Cardiac * No concurrent cardiac abnormalities that would preclude study therapy Pulmonary * No concurrent pulmonary abnormalities that would preclude study therapy Other * Not pregnant or nursing * Fertile patients must use effective contraception * No chronic enteropathy * No other prior cancer within the past 5 years except carcinoma in situ of the cervix or curatively treated basal cell skin cancer * No concurrent severe uncontrolled infection * No obstruction or partial obstruction that would interfere with study therapy * No psychological, social, familial, or geographical situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent anticancer biological response modifiers Chemotherapy * No prior chemotherapy (except adjuvant chemotherapy completed more than 6 months ago) * No prior irinotecan * No prior oxaliplatin * No other concurrent chemotherapy Endocrine therapy * No concurrent anticancer hormonal therapy Radiotherapy * At least 4 weeks since prior pelvic radiotherapy * No prior abdominopelvic radiotherapy Surgery * At least 4 weeks since prior surgery * No prior extensive intestinal resection (i.e., more than 1 prior hemicolectomy or extensive resection of the small intestines) Other * No other concurrent experimental medication * No other concurrent anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (17)

Centre Hospitalier de L' Agglomeration Montargoise

Amilly, 45207, France

Location

Pole Sante Sarthe et Loir Hopital Pierre Daguet

Angers, 49036, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Clinique Sainte-Marguerite

Hyères, 83400, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45100, France

Location

Polyclinique Francheville

Périgueux, 24004, France

Location

Centre Eugene Marquis

Rennes, 35062, France

Location

CHG Roanne

Roanne, F-42300, France

Location

Centre Hospitalier de Rodez

Rodez, 12027, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Centre Hospitalier Regional Metz Thionville

Thionville, 57126, France

Location

Centre Hospitalier General Lucien Hussel

Vienne, 38200, France

Location

Related Publications (1)

  • Becouarn Y, Senesse P, Thezenas S, Boucher E, Adenis A, Cany L, Jacob JH, Cvitkovic F, Montoto-Grillot C, Ychou M; Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan + oxaliplatin, IRINOX) and two standard arms (LV5 FU2 + irinotecan or LV5 FU2 + oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Federation Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007 Dec;18(12):2000-5. doi: 10.1093/annonc/mdm379. Epub 2007 Sep 4.

    PMID: 17785765RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Folfox protocolFluorouracilIrinotecanLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesCoordination ComplexesOrganic Chemicals

Study Officials

  • Yves Becouarn, MD

    Institut Bergonié

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

July 23, 2002

Primary Completion

November 4, 2005

Study Completion

April 1, 2007

Last Updated

March 2, 2021

Record last verified: 2021-02

Locations

FR(17)