Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
NCT ID: NCT00075738
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
INTERVENTIONAL
2003-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cisplatin
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pascal Artru, MD
Role:
Clinique Saint Jean
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinique La Casamance
Abugne, , France
Hopital Saint Andre
Bordeaux, , France
Hopital Drevon
Dijon, , France
Centre Jean Bernard
Le Mans, , France
Centre Hospital Universitaire Hop Huriez
Lille, , France
Clinique Saint Jean
Lyon, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Hopital Bichat - Claude Bernard
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Tenon
Paris, , France
Hopital Haut Leveque
Pessac, , France
Clinique Ste - Marie
Pontoise, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Clinique Francois
Saint-Dizier, , France
Centre Medico-Chirurgical Foch
Suresnes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FRE-GERCOR-D00-2
Identifier Type: -
Identifier Source: secondary_id
EU-20328
Identifier Type: -
Identifier Source: secondary_id
CDR0000349275
Identifier Type: -
Identifier Source: org_study_id