NCT00075595

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable 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

15 active sites

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

June 1, 2002

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
Last Updated

January 6, 2009

Status Verified

August 1, 2007

First QC Date

January 9, 2004

Last Update Submit

January 3, 2009

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

  • Time to progression

  • Time to death from progression

Secondary Outcomes (6)

  • Objective response

  • Stabilization rate

  • Time to treatment failure

  • Duration of response

  • Overall survival rate

  • +1 more secondary outcomes

Interventions

FOLFIRI regimenDRUG
fluorouracilDRUG
irinotecan hydrochlorideDRUG
leucovorin calciumDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal adenocarcinoma * Metastatic, unresectable disease * Meets 1 of the following criteria: * At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan * Evaluable disease * Evidence of disease (e.g., ascites or bone metastases) by imaging techniques * Progressive disease as defined by 1 of the following criteria: * Progressive disease while receiving first-line chemotherapy * Recurrent disease within 6 months after completing adjuvant chemotherapy * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * WHO 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 1.5 times upper limit of normal (ULN) * Alkaline phosphatase \< 3 times ULN Renal * Not specified Cardiovascular * No uncontrolled angina * No myocardial infarction within the past 6 months Gastrointestinal * No chronic diarrhea grade 2 or greater * No unresolved fully or partially obstructed intestine Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other underlying disease or medical condition that would preclude study participation * No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix * No psychological, social, familial, or geographical condition that would preclude study follow-up PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior irinotecan Endocrine therapy * Not specified Radiotherapy * At least 3 weeks since prior radiotherapy Surgery * At least 3 weeks since prior surgery Other * No other concurrent clinical trial participation

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

Sponsors & Collaborators

Study Sites (15)

Hopital Drevon

Dijon, 21000, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

American Hospital of Paris

Neuilly-sur-Seine, F-92202, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Clinique Ste - Marie

Pontoise, 95300, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Clinique de l'Orangerie

Strasbourg, 67010, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

FluorouracilIrinotecanLeucovorin

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 Coenzymes

Study Officials

  • May Mabro, MD

    Hopital Foch

Study Design

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

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

June 1, 2002

Last Updated

January 6, 2009

Record last verified: 2007-08

Locations

FR(15)