Clinical trial NCT00075738: Fluorouracil, Irinotecan, Leucovorin, and Cisplatin as First-Line Therapy in Treating Patients With Metastatic Esophageal Cancer
Official title: Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: stage IV esophageal cancer
recurrent esophageal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-01-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Objective response rate
Secondary outcomes:
measure: Clinical benefit
measure: Tolerability
measure: Local relapse-free survival
measure: Overall survival
Other outcomes:
Locations:
city: Abugne
country: France
facility: Clinique La Casamance
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Dijon
country: France
facility: Hopital Drevon
city: Le Mans
country: France
facility: Centre Jean Bernard
city: Lille
country: France
facility: Centre Hospital Universitaire Hop Huriez
city: Lyon
country: France
facility: Clinique Saint Jean
city: Metz
country: France
facility: Hopital Notre-Dame de Bon Secours
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Tenon
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Pontoise
country: France
facility: Clinique Ste - Marie
city: Saint Brieuc
country: France
facility: Clinique Armoricaine De Radiologie
city: Saint-Dizier
country: France
facility: Clinique Francois
city: Suresnes
country: France
facility: Centre Medico-Chirurgical Foch
Study officials:
affiliation: Clinique Saint Jean
name: Pascal Artru, MD
References: