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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075738
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: cisplatin
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical benefit [ Designated as safety issue: No ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Local relapse-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Study Start Date: October 2003
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075738

Locations
France
Clinique La Casamance
Abugne, France, 13400
Hopital Saint Andre
Bordeaux, France, 33075
Hopital Drevon
Dijon, France, 21000
Centre Jean Bernard
Le Mans, France, 72000
Centre Hospital Universitaire Hop Huriez
Lille, France, 59037
Clinique Saint Jean
Lyon, France, 69008
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Haut Leveque
Pessac, France, 33604
Clinique Ste - Marie
Pontoise, France, 95300
Clinique Armoricaine De Radiologie
Saint Brieuc, France, F-22015
Clinique Francois
Saint-Dizier, France, 52100
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Investigator: Pascal Artru, MD Clinique Saint Jean
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00075738     History of Changes
Other Study ID Numbers: CDR0000349275, FRE-GERCOR-D00-2, EU-20328
Study First Received: January 9, 2004
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV esophageal cancer
recurrent esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
Fluorouracil
Irinotecan
Levoleucovorin
Antidotes
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014