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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00238147
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : May 17, 2013
Information provided by:
University of Washington

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 dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: capecitabine Drug: carboplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 1

Detailed Description:



  • Determine the maximum tolerated dose and dose-limiting toxicity of docetaxel when administered with carboplatin and capecitabine as neoadjuvant induction therapy in patients with locally advanced esophageal cancer.


  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  • Determine the clinical and pathological response in these patients treated with neoadjuvant induction therapy comprising docetaxel, carboplatin, and capecitabine followed by chemoradiotherapy with capecitabine.

OUTLINE: This is an open-label, dose-escalation study of docetaxel.

  • Induction therapy: Patients receive docetaxel IV and carboplatin IV over 30-60 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 2 courses.

Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Approximately 7 days after completion of induction therapy, patients proceed to chemoradiotherapy.

  • Chemoradiotherapy: Patients receive oral capecitabine twice daily on days 1-42 and undergo radiotherapy once daily, 5 days a week, on days 1-40.
  • Surgery: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery.

After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial With Weekly Docetaxel, Capecitabine and Carboplatin as Induction Chemotherapy Followed by Concomitant Capecitabine and Radiotherapy in Patients With Locally Advanced Esophageal Cancer
Study Start Date : September 2004
Actual Study Completion Date : August 2008

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL


  • 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


  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance ≥ 80 mL/min


  • 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


  • Able to swallow tablets
  • Intact upper gastrointestinal tract
  • No malabsorption syndrome


  • 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


  • 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



  • No prior chemotherapy


  • No prior radiotherapy


  • More than 28 days since prior investigational drugs
  • No concurrent warfarin for active anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00238147

United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Principal Investigator: Sujata Rao, MD Seattle Cancer Care Alliance

Publications of Results:
Rao S, Oelschlager BK, Koh WJ, et al.: Phase I trial with weekly docetaxel, capecitabine and carboplatin followed by concomitant capecitabine and radiotherapy in patients with locally advanced esophageal cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-123, 2008. Identifier: NCT00238147     History of Changes
Other Study ID Numbers: 6227
CDR0000445238 ( Registry Identifier: PDQ )
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013

Keywords provided by University of Washington:
stage II esophageal cancer
stage III esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic