Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 75	Other	FRE-GERCOR-D00-2 EU-20328, NCT00075738

Objectives

Primary

1. Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy.

Secondary

1. Determine the clinical benefit in patients treated with this regimen.
2. Determine the tolerability of this regimen in these patients.
3. Determine local relapse-free survival of patients treated with this regimen.
4. Determine the overall survival of patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 to 75

Performance status

• ECOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³

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

Expected Enrollment

A total of 39 patients will be accrued for this study within 1 year.

Outcomes

Objective response rate

Clinical benefit
Tolerability
Local relapse-free survival
Overall survival

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.

Trial Contact Information

Trial Lead Organizations

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Pascal Artru, MD, Study coordinator		Ph: 33-4-7878-1010 Email: dr.artru@wanadoo.fr

Registry Information
Official Title		Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
Trial Start Date		2003-10-29
Registered in ClinicalTrials.gov		NCT00075738
Date Submitted to PDQ		2003-12-04
Information Last Verified		2007-07-31

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