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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2007 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on January 9, 2004. Last Updated on July 23, 2008 History of Changes

Sponsor:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075738

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 II

Study Type:	Interventional
Study Design:	Masking: 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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Fluorouracil Leucovorin Cisplatin Citrovorum factor Irinotecan U 101440E Irinotecan hydrochloride Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

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

Primary Outcome Measures:

Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical benefit [ Designated as safety issue: No ]
Tolerability [ Designated as safety issue: Yes ]
Local relapse-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Hopital Bichat - Claude Bernard
Paris, France, 75018
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

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Investigator:

Pascal Artru, MD

Clinique Saint Jean

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00075738 History of Changes
Other Study ID Numbers:	CDR0000349275, FRE-GERCOR-D00-2, EU-20328
Study First Received:	January 9, 2004
Last Updated:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV esophageal cancer
recurrent esophageal cancer

Additional relevant MeSH terms:

Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Irinotecan
Cisplatin
Fluorouracil
Camptothecin
Leucovorin
Levoleucovorin

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on February 09, 2012