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

July 23, 2008 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

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.

Study Overview

Status

Unknown

Conditions

Esophageal Cancer

Intervention / Treatment

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.

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Objective response rate

Secondary Outcome Measures

Outcome Measure
Overall survival
Tolerability
Clinical benefit
Local relapse-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

Pascal Artru, MD, Clinique Saint Jean

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 12, 2004

First Posted (Estimate)

January 13, 2004

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000349275
FRE-GERCOR-D00-2
EU-20328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.