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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00075738
First Posted: January 13, 2004
Last Update Posted: July 24, 2008
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer Drug: cisplatin Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate

Secondary Outcome Measures:
  • Clinical benefit
  • Tolerability
  • Local relapse-free survival
  • Overall survival

Study Start Date: October 2003
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075738


Locations
France
Clinique La Casamance
Abugne, France, 13400
Hopital Saint Andre
Bordeaux, France, 33075
Hopital Drevon
Dijon, France, 21000
Centre Jean Bernard
Le Mans, France, 72000
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Clinique Saint Jean
Lyon, France, 69008
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Hopital Haut Leveque
Pessac, France, 33604
Clinique Ste - Marie
Pontoise, France, 95300
Clinique Armoricaine De Radiologie
Saint Brieuc, France, F-22015
Clinique Francois
Saint-Dizier, France, 52100
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
OverallOfficial: Pascal Artru, MD Clinique Saint Jean
  More Information

ClinicalTrials.gov Identifier: NCT00075738     History of Changes
Other Study ID Numbers: CDR0000349275
FRE-GERCOR-D00-2
EU-20328
First Submitted: January 9, 2004
First Posted: January 13, 2004
Last Update Posted: July 24, 2008
Last Verified: July 2007

Keywords provided by National Cancer Institute (NCI):
stage IV esophageal cancer
recurrent esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Irinotecan
Cisplatin
Camptothecin
Fluorouracil
Levoleucovorin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents