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A Phase I Study of Oral Capecitabine in Combination With Weekly IV Carboplatin/Paclitaxel and Radiation Therapy for Patients

Phase 1
18 Years
Not Enrolling
Esophageal Cancer

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Trial Information

A Phase I Study of Oral Capecitabine in Combination With Weekly IV Carboplatin/Paclitaxel and Radiation Therapy for Patients



- 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

- 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.

Inclusion Criteria


- Histologically confirmed carcinoma of the thoracic esophagus or gastroesophageal
junction for which bimodality treatment with chemotherapy and radiotherapy is

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Herbert I. Hurwitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

September 2003

Completion Date:

July 2007

Related Keywords:

  • Esophageal Cancer
  • stage I esophageal cancer
  • stage II esophageal cancer
  • stage III esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Duke Comprehensive Cancer Center Durham, North Carolina  27710