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Status unknownNCT00075738Updated Jul 24, 2008

Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer

A Phase 2 interventional study of cisplatin and fluorouracil in Esophageal Cancer, sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group. Status unknown at 15 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-07-24.

Sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy.

Secondary

  • Determine the clinical benefit in patients treated with this regimen.
  • Determine the tolerability of this regimen in these patients.
  • Determine local relapse-free survival of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive irinotecan IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours and cisplatin IV over 30 minutes on days 1 and 2. Treatment repeats every 15 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study within 1 year.

02

Conditions studied

  • Esophageal Cancer

Keywords

  • stage IV esophageal cancer
  • recurrent esophageal cancer
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

Browse Esophageal Neoplasms studies →

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group is the lead sponsor of 76 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • Drugcisplatin
  • Drugfluorouracil
  • Drugirinotecan hydrochloride
  • Drugleucovorin calcium
06

What researchers measure

Primary outcomes

  1. Objective response rate

Secondary outcomes

  1. Clinical benefit

  2. Tolerability

  3. Local relapse-free survival

  4. Overall survival

07

Study locations

15 sites
  • Clinique La Casamance
    Abugne, 13400, France
  • Hopital Saint Andre
    Bordeaux, 33075, France
  • Hopital Drevon
    Dijon, 21000, France
  • Centre Jean Bernard
    Le Mans, 72000, France
  • Centre Hospital Universitaire Hop Huriez
    Lille, 59037, France
  • Clinique Saint Jean
    Lyon, 69008, France
  • Hopital Notre-Dame de Bon Secours
    Metz, 57038, France
  • Hopital Bichat - Claude Bernard
    Paris, 75018, France
  • Hopital Saint Antoine
    Paris, 75571, France
  • Hopital Tenon
    Paris, 75970, France
  • Hopital Haut Leveque
    Pessac, 33604, France
  • Clinique Ste - Marie
    Pontoise, 95300, France
  • Clinique Armoricaine De Radiologie
    Saint Brieuc, F-22015, France
  • Clinique Francois
    Saint-Dizier, 52100, France
  • Centre Medico-Chirurgical Foch
    Suresnes, 92151, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00075738
Lead sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
First posted
Jan 13, 2004
Start date
Oct 2003
Last update
Jul 24, 2008

Study contacts

Pascal Artru, MD
Clinique Saint Jean
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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