Combination Chemotherapy and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
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.
|Esophageal Cancer||Drug: capecitabine Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy||Phase 1|
|Study Design:||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|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281788
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Herbert I. Hurwitz, MD||Duke Cancer Institute|