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.
Masking: Open Label, Primary Purpose: Treatment
Herbert I. Hurwitz, MD
Duke Cancer Institute
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|