Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
Data Collection
Digestive System Diseases+6
+ Digestive System Neoplasms
+ Esophageal Diseases
Treatment Study
Summary
Study start date: October 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
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
Hopital Saint Andre
Bordeaux, FranceHopital Drevon
Dijon, FranceCentre Jean Bernard
Le Mans, France