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

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: fluorouracil
* Drug: irinotecan hydrochloride
* Drug: leucovorin calcium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: fluorouracil|nan|
|Drug: irinotecan hydrochloride|nan|
|Drug: leucovorin calcium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical benefit |  |  | 
| Tolerability |  |  | 
| Local relapse-free survival |  |  | 
| Overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV esophageal cancer, recurrent esophageal cancer