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Status:

COMPLETED

Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Esophageal Cancer

Lead Sponsor:

University of Washington

Conditions:

Esophageal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from ...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose and dose-limiting toxicity of docetaxel when administered with carboplatin and capecitabine as neoadjuvant induction therapy in patients wi...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed esophageal or gastroesophageal junction cancer
  • Locally advanced disease, meeting 1 of the following staging criteria:
  • T3, N0, M0 disease
  • Any T, N1, M0 disease
  • Measurable or evaluable disease
  • PATIENT CHARACTERISTICS:
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Granulocyte count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 8.0 g/dL
  • Hepatic
  • Bilirubin normal
  • Meets 1 of the following criteria:
  • Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST/ALT normal
  • Renal
  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance ≥ 80 mL/min
  • Cardiovascular
  • No uncontrolled congestive heart failure
  • No symptomatic coronary artery disease
  • No uncontrolled arrhythmias
  • No myocardial infarction within the past 12 months
  • No other uncontrolled clinically significant cardiac disease
  • Gastrointestinal
  • Able to swallow tablets
  • Intact upper gastrointestinal tract
  • No malabsorption syndrome
  • Immunologic
  • No history of unanticipated severe reaction to fluoropyrimidine
  • No known hypersensitivity to fluorouracil
  • No severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No serious infection that requires continuous antibiotic therapy
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
  • No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No history of seizures
  • No history of serious psychiatric illness that would preclude study compliance or giving informed consent
  • No peripheral neuropathy \> grade 1
  • PRIOR CONCURRENT THERAPY:
  • Chemotherapy
  • No prior chemotherapy
  • Radiotherapy
  • No prior radiotherapy
  • Other
  • More than 28 days since prior investigational drugs
  • No concurrent warfarin for active anticoagulation

Exclusion

    Key Trial Info

    Start Date :

    September 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2008

    Estimated Enrollment :

    18 Patients enrolled

    Trial Details

    Trial ID

    NCT00238147

    Start Date

    September 1 2004

    End Date

    August 1 2008

    Last Update

    May 17 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Seattle Cancer Care Alliance

    Seattle, Washington, United States, 98109-1023

    2

    University of Washington School of Medicine

    Seattle, Washington, United States, 98195