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

This study has been completed.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00238147
First received: October 12, 2005
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Esophageal Cancer
 Drug: capecitabine
Drug: carboplatin
Drug: docetaxel
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
 Phase 1

Study Type: Interventional
Study Design: Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Estimated Enrollment: 18
Study Start Date: September 2004
Study Completion Date: August 2008
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 with locally advanced esophageal cancer.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238147

Locations
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
Investigators
Principal Investigator: Sujata Rao, MD Seattle Cancer Care Alliance
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.

ClinicalTrials.gov Identifier: NCT00238147     History of Changes
Other Study ID Numbers: 6227, UWCC-UW-6227, AVENTIS-UW-03031, ROCHE-UW-03031, UW-03031, UWCC-04-2311-D-01, CDR0000445238
Study First Received: October 12, 2005
Last Updated: May 15, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
 Docetaxel
Capecitabine
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013