NCT00006468

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is more effective for metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have metastatic colorectal cancer.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

January 13, 2009

Status Verified

December 1, 2000

First QC Date

November 6, 2000

Last Update Submit

January 10, 2009

Conditions

Colorectal Cancer

Keywords

stage IV colon cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal canceradenocarcinoma of the colonadenocarcinoma of the rectum

Interventions

FOLFOX regimenDRUG
fluorouracilDRUG
leucovorin calciumDRUG
oxaliplatinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed unresectable metastatic adenocarcinoma of the colon or rectum * Bidimensionally measurable or evaluable disease outside previously irradiated area * No bone metastasis as target lesion * At least 1 cm if spiral CT scan OR * At least 2 cm if conventional CT scan * No CNS metastasis * No symptomatic ascites or pleural effusion that is not evacuated * No total or partial bowel obstruction PATIENT CHARACTERISTICS: Age: * 18 to 80 Performance status: * ECOG 0-2 * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Alkaline phosphatase less than 5 times upper limit of normal (ULN) Renal: * Creatinine less than 3 times ULN * No uncontrolled hypercalcemia Cardiovascular: * No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias Other: * No peripheral sensory neuropathy * No prior significant neurologic or psychiatric disorders * No other malignancy within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma * No active infection * No other concurrent serious disease * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for metastatic disease Chemotherapy: * Prior adjuvant chemotherapy allowed, provided progression-free interval of more than 6 months since end of last course * No prior oxaliplatin or irinotecan * No prior chemotherapy for metastatic disease * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy Surgery: * Concurrent surgery allowed Other: * At least 30 days since other prior investigational drugs * No other concurrent investigational treatment * No other concurrent antitumoral treatment

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

Sponsors & Collaborators

Study Sites (1)

Hopital Saint Antoine

Paris, 75571, France

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Folfox protocolFluorouracilLeucovorinOxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Aimery de Gramont, MD

    Hopital Saint Antoine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2000

First Posted

January 27, 2003

Study Start

January 1, 2000

Last Updated

January 13, 2009

Record last verified: 2000-12

Locations

FR(1)