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Status:

UNKNOWN

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

Lead Sponsor:

GERCOR - Multidisciplinary Oncology Cooperative Group

Conditions:

Esophageal Cancer

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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 th...

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 thera...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    October 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00075738

    Start Date

    October 1 2003

    Last Update

    July 24 2008

    Active Locations (15)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (15 locations)

    1

    Clinique La Casamance

    Abugne, France, 13400

    2

    Hopital Saint Andre

    Bordeaux, France, 33075

    3

    Hopital Drevon

    Dijon, France, 21000

    4

    Centre Jean Bernard

    Le Mans, France, 72000