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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00075738
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2004
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

January 9, 2004
January 13, 2004
July 24, 2008
October 2003
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Objective response rate
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Complete list of historical versions of study NCT00075738 on Archive Site
  • Clinical benefit
  • Tolerability
  • Local relapse-free survival
  • Overall survival
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Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus

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.



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


  • 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.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Esophageal Cancer
  • Drug: cisplatin
  • Drug: fluorouracil
  • Drug: irinotecan hydrochloride
  • Drug: leucovorin calcium
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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  • 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



  • 18 to 75

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • Absolute neutrophil count ≥ 1,500/mm^3


  • Bilirubin ≤ 1.5 times normal
  • Alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present)
  • SGOT and SGPT ≤ 3 times normal


  • Creatinine ≤ 1.5 mg/dL


  • No myocardial infarction within the past 6 months
  • No uncontrolled angina


  • 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


Biologic therapy

  • Not specified


  • More than 6 months since prior fluorouracil and/or cisplatin
  • No other prior chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • More than 6 weeks since prior radiotherapy


  • More than 4 weeks since prior surgery


  • No concurrent participation in another clinical study
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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GERCOR - Multidisciplinary Oncology Cooperative Group
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Investigator: Pascal Artru, MD Clinique Saint Jean
National Cancer Institute (NCI)
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP