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
- 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
- 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: 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
After completion of study treatment, patients are followed periodically for 5 years and then
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Sujata Rao, MD
Seattle Cancer Care Alliance
United States: Federal Government
|University of Washington School of Medicine||Seattle, Washington 98195|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|