Combination Chemotherapy and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction 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: NCT00281788
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : March 21, 2013
National Cancer Institute (NCI)
Information provided by:
Duke University

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as capecitabine, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal cancer or gastroesophageal junction cancer.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: capecitabine Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy Phase 1

Detailed Description:



  • Determine the maximum tolerated dose and recommended phase II dose of capecitabine when administered with carboplatin, paclitaxel, and radiotherapy in patients with carcinoma of the esophagus or gastroesophageal junction.


  • Determine the radiographic and pathologic response rate in patients treated with this regimen.
  • Correlate, preliminarily, tumor biomarker response with clinical response in patients treated with this regimen.

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

Patients undergo radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 and carboplatin IV over 30 minutes and paclitaxel IV over 1 hour on day 2. Treatment repeats weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. Beginning at week 9 (4 weeks after completing chemoradiotherapy), some patients may undergo surgery to remove the tumor. Patients with unresectable or gross residual disease after completing radiotherapy may continue to receive capecitabine, carboplatin, and paclitaxel for as long as the chemotherapy is beneficial.

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

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral Capecitabine in Combination With Weekly IV Carboplatin/Paclitaxel and Radiation Therapy for Patients
Study Start Date : September 2003
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

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 carcinoma of the thoracic esophagus or gastroesophageal junction for which bimodality treatment with chemotherapy and radiotherapy is indicated
  • No tumors that extend above the level of the thoracic inlet or beyond 4 cm below the gastroesophageal junction
  • No esophageal perforation based on radiographic or bronchoscopic evidence
  • No known brain metastases, lymphangitic lung metastases, or carcinomatous meningitis


  • Karnofsky performance status ≥ 70%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • AST or ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 mg/dL
  • Creatinine ≤ 1.5 times ULN
  • Calcium ≤ 1.3 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection or other serious underlying medical condition that would preclude study treatment
  • No dementia or significantly altered mental status that would preclude understanding or giving informed consent


  • No prior chemotherapy or radiotherapy
  • No other concurrent investigational therapy

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): NCT00281788

United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
Principal Investigator: Herbert I. Hurwitz, MD Duke Cancer Institute Identifier: NCT00281788     History of Changes
Other Study ID Numbers: 4950
CDR0000449942 ( Other Identifier: NCI )
First Posted: January 25, 2006    Key Record Dates
Last Update Posted: March 21, 2013
Last Verified: April 2008

Keywords provided by Duke University:
stage I esophageal cancer
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
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic