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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase

Unknown

Phase 2

Conditions

Esophageal Cancer

Treatments

Drug: cisplatin

Drug: leucovorin calcium

Drug: irinotecan hydrochloride

Drug: fluorouracil

Study type

Interventional

Funder types

Other

Identifiers

NCT00075738

FRE-GERCOR-D00-2

EU-20328

CDR0000349275

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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