NCT00075738

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and cisplatin, work in 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 combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal 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

October 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2004

Completed
Last Updated

July 24, 2008

Status Verified

July 1, 2007

First QC Date

January 9, 2004

Last Update Submit

July 23, 2008

Conditions

Esophageal Cancer

Keywords

stage IV esophageal cancerrecurrent esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

Secondary Outcomes (4)

  • Clinical benefit

  • Tolerability

  • Local relapse-free survival

  • Overall survival

Interventions

cisplatinDRUG
fluorouracilDRUG
irinotecan hydrochlorideDRUG
leucovorin calciumDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed esophageal cancer * Metastatic disease * At least 1 unidimensionally measurable metastatic lesion * At least 10 mm by spiral scanner OR 20 mm by sequential scanner * Outside the field of prior radiotherapy * No known symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 1.5 times normal * Alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present) * SGOT and SGPT ≤ 3 times normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * No uncontrolled angina Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No other illness or medical condition that would preclude study participation * No psychological, social, familial, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 6 months since prior fluorouracil and/or cisplatin * No other prior chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 6 weeks since prior radiotherapy Surgery * More than 4 weeks since prior surgery Other * No concurrent participation in another clinical study

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

Sponsors & Collaborators

Study Sites (15)

Clinique La Casamance

Abugne, 13400, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Clinique Saint Jean

Lyon, 69008, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Clinique Ste - Marie

Pontoise, 95300, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Clinique Francois

Saint-Dizier, 52100, France

Location

Centre Medico-Chirurgical Foch

Suresnes, 92151, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

CisplatinFluorouracilIrinotecanLeucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Officials

  • Pascal Artru, MD

    Clinique Saint Jean

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 13, 2004

Study Start

October 1, 2003

Last Updated

July 24, 2008

Record last verified: 2007-07

Locations

FR(15)