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

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cisplatin
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage IV esophageal cancer, recurrent esophageal cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique La Casamance
  • Hopital Saint Andre
  • Hopital Drevon
  • Centre Jean Bernard
  • Centre Hospital Universitaire Hop Huriez
  • Clinique Saint Jean
  • Hopital Notre-Dame de Bon Secours
  • Hopital Bichat - Claude Bernard
  • Hopital Saint Antoine
  • Hopital Tenon
  • Hopital Haut Leveque
  • Clinique Ste - Marie
  • Clinique Armoricaine De Radiologie
  • Clinique Francois
  • Centre Medico-Chirurgical Foch

Outcomes

Primary Outcome Measures

Objective response rate

Secondary Outcome Measures

Clinical benefit
Tolerability
Local relapse-free survival
Overall survival

Full Information

First Posted
January 9, 2004
Last Updated
July 23, 2008
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00075738
Brief Title
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

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
stage IV esophageal cancer, recurrent esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Primary Outcome Measure Information:
Title
Objective response rate
Secondary Outcome Measure Information:
Title
Clinical benefit
Title
Tolerability
Title
Local relapse-free survival
Title
Overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Artru, MD
Organizational Affiliation
Clinique Saint Jean
Facility Information:
Facility Name
Clinique La Casamance
City
Abugne
ZIP/Postal Code
13400
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Clinique Saint Jean
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Clinique Ste - Marie
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieuc
ZIP/Postal Code
F-22015
Country
France
Facility Name
Clinique Francois
City
Saint-Dizier
ZIP/Postal Code
52100
Country
France
Facility Name
Centre Medico-Chirurgical Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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