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

Esophageal Cancer Clinical Trial

Official title:

Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00075738
• Other study ID #: CDR0000349275
• Secondary ID: FRE-GERCOR-D00-2
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 9, 2004
• Last updated: July 23, 2008
• Start date: October 2003

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

• irinotecan hydrochloride

• leucovorin calcium

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate			No
Secondary	Clinical benefit			No
Secondary	Tolerability			Yes
Secondary	Local relapse-free survival			No
Secondary	Overall survival			No