S0408: Capecitabine, Oxaliplatin, and Bevacizumab in Pts Undergoing Surgery for Liver Mets From Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00118105|
Recruitment Status : Withdrawn (Budget Constraints)
First Posted : July 11, 2005
Last Update Posted : January 3, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer||Biological: bevacizumab Drug: capecitabine Drug: oxaliplatin Procedure: conventional surgery||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Neoadjuvant Capecitabine, Oxaliplatin, and Bevacizumab for Resectable Colorectal Metastases in the Liver|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
Experimental: Chemotherapy + Surgery + Chemotherapy
Preoperative Neoadjuvant Chemotherapy
Conventional surgery: After 4 cycles of chemotherapy
Postoperative Neoadjuvant Chemotherapy
Preoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3 Postoperative: 7.5 mg/kg, IV, Day 1 of cycles 1,2,3,4
Pre & Post Operative: 1,700 mg/m^2/day, PO at 12 hr interval, Days 1-14 of cycles 1,2,3,4
130 mg/m^2, IV, Day 1 of cycles 1,2,3,4
Other Name: NSC-266046
Procedure: conventional surgery
- Proportion of patients with R0 resection after treatment [ Time Frame: 16-18 weeks from registration ]
- Probability of nonprogression (i.e., stable disease or response [complete and partial, confirmed and unconfirmed]) [ Time Frame: 12 weeks from registration ]
- Comparison of patients achieving R0 resection with literature [ Time Frame: 16-18 weeks from registration ]
- Overall survival [ Time Frame: Up to 3 years ]
- Disease-free survival [ Time Frame: Up to 3 years ]
- Positron emission tomography response [ Time Frame: Registration and 12 weeks ]
- Correlation of clinical outcome with expression of biomarkers and telomere length [ Time Frame: Up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118105
|Principal Investigator:||Jean-Nicolas Vauthey, MD||M.D. Anderson Cancer Center|
|Principal Investigator:||Robert de W. Marsh, MD||University of Florida|
|Principal Investigator:||Cathy Eng, MD||M.D. Anderson Cancer Center|
|Principal Investigator:||Henry Q. Xiong, MD, PhD||M.D. Anderson Cancer Center|
|Principal Investigator:||Kevin G. Billingsley, MD||OHSU Knight Cancer Institute|
|Principal Investigator:||Steven A. Curley, MD||M.D. Anderson Cancer Center|