Phase II Trial of Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
- Evaluate the toxicity and safety of bevacizumab when given together with cisplatin,
irinotecan hydrochloride, and radiotherapy followed by surgery and adjuvant bevacizumab
in patients with locally advanced esophageal adenocarcinoma.
- Observe the rate of pathologic complete response in patients treated with this regimen.
- Observe overall survival, disease-free survival, and patterns of failure in these
- Clarify toxicity and tolerability of this regimen.
- Evaluate pre-treatment levels of vascular endothelial growth factor in patient serum as
a corollary of response to this regimen.
- Correlate serum proteomics data with complete pathologic response.
OUTLINE: This is a nonrandomized, open-label study.
- Induction therapy: Patients receive cisplatin IV over 30 minutes and irinotecan
hydrochloride IV over 30 minutes on days 1, 8, 22, and 29. Patients also receive
bevacizumab IV over 30-90 minutes on days 1 and 22.
- Combination therapy and radiotherapy: Patients receive cisplatin and irinotecan
hydrochloride as in induction chemotherapy on days 43, 50, 64, and 71. Patients also
receive bevacizumab IV over 30-90 minutes on days 43 and 64. Patients undergo external
beam radiotherapy 5 days a week for 6 weeks beginning on day 43.
- Surgery: Patients undergo surgery 6-8 weeks after finishing combination therapy and
- Maintenance therapy: Approximately 6 weeks after surgery, patients receive bevacizumab
IV over 30-90 minutes every 3 weeks for 6 months.
Blood samples are obtained at baseline, after finishing chemoradiotherapy, and prior to
maintenance therapy and are examined by the matrix-assisted laser-desorption ionization time
of flight (MALDI-TOF) mass spectometry for proteomic profiling.
After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
David H. Ilson, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
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