A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver
- Determine the proportion of patients with resectable hepatic metastases secondary to
colorectal cancer who undergo surgical resection and achieve a R0 resection after
treatment with neoadjuvant capecitabine, oxaliplatin, and bevacizumab.
- Determine the probability of non-progression (i.e., stable disease or response
[complete and partial, confirmed and unconfirmed]) in patients treated with this
- Compare the proportion of patients treated with this regimen who undergo surgical
resection and those who achieve a R0 resection with that described in the literature.
- Determine overall survival and disease-free survival of patients treated with this
- Determine response by positron emission tomography in patients treated with this
- Correlate clinical outcome with expression of biomarkers (e.g., thymidylate synthase,
dihydropyrimidine dehydrogenase, thymidine phosphorylase, excision repair cross
complementing 1, and hTERT) and telomere length in patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Neoadjuvant therapy: Patients receive bevacizumab* IV over 30-90 minutes and
oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14.
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
NOTE: *Bevacizumab is administered during courses 1-3 of neoadjuvant therapy.
- Surgery: Approximately 3-4 weeks after completion of neoadjuvant therapy, patients are
evaluated. Patients with unresectable disease are removed from the study. Patients with
resectable disease undergo surgical resection of liver metastases within 4-6 weeks
after completion of neoadjuvant therapy.
- Adjuvant therapy: Beginning at least 28 days after surgical resection, patients with at
least stable disease after completion of neoadjuvant therapy receive 4 courses of
adjuvant bevacizumab**, oxaliplatin, and capecitabine as in neoadjuvant therapy.
NOTE: **Bevacizumab is administered during courses 1-4 of adjuvant therapy.
After completion of study treatment, patients are followed every 4 months until disease
progression and then every 6 months for up to 3 years from study entry.
PROJECTED ACCRUAL: Approximately 35-65 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with R0 resection after treatment
16-18 weeks from registration
Jean-Nicolas Vauthey, MD
M.D. Anderson Cancer Center
United States: Federal Government
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|Rush-Copley Cancer Care Center||Aurora, Illinois 60507|
|Joliet Oncology-Hematology Associates, Limited - West||Joliet, Illinois 60435|
|Carle Cancer Center at Carle Foundation Hospital||Urbana, Illinois 61801|
|Saint Anthony Memorial Health Centers||Michigan City, Indiana 46360|
|Bronson Methodist Hospital||Kalamazoo, Michigan 49007|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Borgess Medical Center||Kalamazooaa, Michigan 49001|
|St. Rita's Medical Center||Lima, Ohio 45801|
|CCOP - Montana Cancer Consortium||Billings, Montana 59101|
|Veterans Affairs Medical Center - Dayton||Dayton, Ohio 45428|
|CCOP - Dayton||Kettering, Ohio 45429|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|Great Falls Clinic||Great Falls, Montana 59405|
|Cancer Research Center at Boston Medical Center||Boston, Massachusetts 02118|
|Northern Rockies Radiation Oncology Center||Billings, Montana 59101|
|Hematology-Oncology Centers of the Northern Rockies - Billings||Billings, Montana 59101|
|St. Vincent Healthcare||Billings, Montana 59101|
|Deaconess Billings Clinic - Downtown||Billings, Montana 59101|
|St. James Community Hospital||Butte, Montana 59701|
|St. Peter's Hospital||Helena, Montana 59601|
|Kalispell Medical Oncology||Kalispell, Montana 59901|
|Kalispell Regional Medical Center||Kalispell, Montana 59901|
|Glacier Oncology, PLLC||Kalispell, Montana 59901|
|Montana Cancer Center at St. Patrick Hospital and Health Sciences Center||Missoula, Montana 59802|
|Montana Cancer Specialists at Montana Cancer Center||Missoula, Montana 59802|
|Community Medical Center||Missoula, Montana 59801|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|St. Francis Hospital and Health Centers - Beech Grove Campus||Beech Grove, Indiana 46107|
|Reid Hospital & Health Care Services, Incorporated||Richmond, Indiana 47374|
|Samaritan North Cancer Care Center||Dayton, Ohio 45415|
|Grandview Hospital||Dayton, Ohio 45405|
|David L. Rike Cancer Center at Miami Valley Hospital||Dayton, Ohio 45409|
|Good Samaritan Hospital||Dayton, Ohio 45406|
|Blanchard Valley Medical Associates||Findlay, Ohio 45840|
|Charles F. Kettering Memorial Hospital||Kettering, Ohio 45429|
|Middletown Regional Hospital||Middletown, Ohio 45044|
|UVMC Cancer Care Center at Upper Valley Medical Center||Troy, Ohio 45373-1300|
|Ruth G. McMillan Cancer Center at Greene Memorial Hospital||Xenia, Ohio 45385|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Welch Cancer Center at Sheridan Memorial Hospital||Sheridan, Wyoming 82801|
|Tammy Walker Cancer Center at Salina Regional Health Center||Salina, Kansas 67401|
|Bozeman Deaconess Cancer Center||Bozeman, Montana 59715|
|Billings Clinic Cancer Center||Billings, Montana 59107-5100|
|Guardian Oncology and Center for Wellness||Missoula, Montana 59804|
|Frontier Cancer Center||Great Falls, Montana 59405|