S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer
- Conditions
- Colorectal CancerMetastatic Cancer
- Interventions
- Registration Number
- NCT00118105
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving capecitabine and oxaliplatin together with bevacizumab before and after surgery may be an effective treatment for liver metastases.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with bevacizumab works in treating patients who are undergoing surgery for liver metastases due to colorectal cancer.
- Detailed Description
OBJECTIVES:
* 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 regimen.
* 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 regimen.
* Determine response by positron emission tomography in patients treated with this regimen.
* 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 unacceptable toxicity.
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chemotherapy + Surgery + Chemotherapy bevacizumab Preoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Conventional surgery: After 4 cycles of chemotherapy Postoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Chemotherapy + Surgery + Chemotherapy conventional surgery Preoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Conventional surgery: After 4 cycles of chemotherapy Postoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Chemotherapy + Surgery + Chemotherapy capecitabine Preoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Conventional surgery: After 4 cycles of chemotherapy Postoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Chemotherapy + Surgery + Chemotherapy oxaliplatin Preoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4 Conventional surgery: After 4 cycles of chemotherapy Postoperative Neoadjuvant Chemotherapy * Bevacizumab, 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4 * Oxaliplatin, 130 mg/m\^2, IV, Day 1 of cycles 1,2,3,4 * Capecitabine, 1,700 mg/m\^2/day divided, PO at 12 hr intervals, Days 1-14 of cycles 1,2,3,4
- Primary Outcome Measures
Name Time Method Proportion of patients with R0 resection after treatment 16-18 weeks from registration Comparison of patients achieving R0 resection with literature 16-18 weeks from registration Overall survival Up to 3 years Probability of nonprogression (i.e., stable disease or response [complete and partial, confirmed and unconfirmed]) 12 weeks from registration Disease-free survival Up to 3 years Positron emission tomography response Registration and 12 weeks Correlation of clinical outcome with expression of biomarkers and telomere length Up to 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Cancer Research Center at Boston Medical Center
🇺🇸Boston, Massachusetts, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Frontier Cancer Center
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Borgess Medical Center
🇺🇸Kalamazooaa, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States