Suspended

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

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What is being tested

cisplatin

+ fluorouracil
+ irinotecan hydrochloride
Drug
Who is being recruted

Esophageal Cancer

From 18 to 75 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003

Summary

Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: July 24, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitlePhase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus 
Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: July 24, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Esophageal Cancer
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


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 15 locations
Suspended
Clinique La CasamanceAbugne, FranceSee the location
Suspended
Hopital Saint AndreBordeaux, France
Suspended
Hopital DrevonDijon, France
Suspended
Centre Jean BernardLe Mans, France

Suspended15 Study Centers