Back to resultsOxaliplatin, Capecitabine, and Bevacizumab Followed By Surgery and/or Radiofrequency Ablation in Patients With Colorectal Cancer
Primary Purpose
Colorectal Cancer, Metastatic Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
capecitabine
oxaliplatin
conventional surgery
neoadjuvant therapy
radiofrequency ablation
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal adenocarcinoma metastatic to the liver
- Unresectable liver metastases
- Measurable disease
- No evidence of extrahepatic metastases
- No CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 45 mL/min
- Urinary protein < 2+ by dipstick OR < 2 g by 24-hour urine collection
- Bilirubin < 2 times ULN
- SGOT and SGPT < 2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 18 months after completion of study therapy
- Able to take oral medications (e.g., no dysphagia or malabsorption symptoms)
- No other prior malignancy unless in complete remission and off therapy for ≥ 5 years
- No known allergy to the study drugs
- No peripheral neuropathy > grade 1
- No uncontrolled infection
- No uncontrolled hypertension
- No active bleeding or hemoptysis
No other serious concurrent illness within the past 12 months, including any of the following:
- Nonstable coronary artery disease
- Myocardial infarction
- Transient ischemic attack
- Cardiovascular accident
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- At least 28 days since prior major surgery
Prior therapy for advanced disease allowed
- No prior oxaliplatin-based therapy
- Concurrent maintenance and palliative treatment during study chemotherapy allowed (e.g., nutritional or transfusional support or pain control)
No concurrent corticosteroids except when used under the following circumstances:
- As oxaliplatin premedication
- Anti-5-HT_3 as antiemetic
- No concurrent cold cap or iced mouth rinses
- No other concurrent chemotherapy
- No placement of hepatic artery port for regional chemotherapy
Sites / Locations
- University of California Davis Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Unresectable colorectal liver mets
Arm Description
Outcomes
Primary Outcome Measures
Conversion rate of nonresectable disease to resectable disease
Secondary Outcome Measures
Disease-free and overall survival
Objective response rate
Duration of response
Full Information
NCT ID
NCT00408772
First Posted
December 6, 2006
Last Updated
June 7, 2017
Sponsor
University of California, Davis
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT00408772
Brief Title
Oxaliplatin, Capecitabine, and Bevacizumab Followed By Surgery and/or Radiofrequency Ablation in Patients With Colorectal Cancer
Official Title
Efficacy of Neoadjuvant XELOX/AVASTIN Therapy for Nonresectable Colorectal Liver Metastases With Secondary Hepatic Resection/Radiofrequency
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of accrual
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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. Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving chemotherapy and bevacizumab before surgery or radiofrequency ablation may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with bevacizumab followed by surgery and/or radiofrequency ablation works in treating patients with colorectal cancer that has spread to the liver and cannot be removed by surgery.
Detailed Description
OBJECTIVES:
Primary
Evaluate the conversion rate of nonresectable disease to resectable disease in patients with nonresectable liver metastases secondary to colorectal adenocarcinoma treated with neoadjuvant therapy comprising oxaliplatin, capecitabine, and bevacizumab followed by hepatic resection and/or radiofrequency ablation.
Evaluate progression-free survival of patients treated with this regimen.
Secondary
Determine disease-free and overall survival of patients treated with this regimen.
Determine the toxicities of this regimen in these patients.
OUTLINE:
Neoadjuvant therapy: Patients receive oxaliplatin IV over 2 hours and bevacizumab IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity or until conversion to resectable disease.
Surgery and/or radiofrequency ablation (RFA): Patients undergo hepatic resection (with or without RFA) when tumor is deemed resectable. Patients with stable (< 8 lesions) and unresectable disease undergo laparoscopic or percutaneous RFA. RFA repeats once 4-6 weeks later.
Adjuvant therapy: Beginning 6-8 weeks after surgery and/or RFA, patients may receive adjuvant therapy comprising oxaliplatin, capecitabine, and bevacizumab, as in neoadjuvant therapy, for up to 4 courses.
After completion of study treatment, patients are followed every 4 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Metastatic Cancer
Keywords
liver metastases, stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unresectable colorectal liver mets
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
radiofrequency ablation
Primary Outcome Measure Information:
Title
Conversion rate of nonresectable disease to resectable disease
Time Frame
48 months
Secondary Outcome Measure Information:
Title
Disease-free and overall survival
Time Frame
48 months
Title
Objective response rate
Time Frame
48 months
Title
Duration of response
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal adenocarcinoma metastatic to the liver
Unresectable liver metastases
Measurable disease
No evidence of extrahepatic metastases
No CNS metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Absolute neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 45 mL/min
Urinary protein < 2+ by dipstick OR < 2 g by 24-hour urine collection
Bilirubin < 2 times ULN
SGOT and SGPT < 2 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 18 months after completion of study therapy
Able to take oral medications (e.g., no dysphagia or malabsorption symptoms)
No other prior malignancy unless in complete remission and off therapy for ≥ 5 years
No known allergy to the study drugs
No peripheral neuropathy > grade 1
No uncontrolled infection
No uncontrolled hypertension
No active bleeding or hemoptysis
No other serious concurrent illness within the past 12 months, including any of the following:
Nonstable coronary artery disease
Myocardial infarction
Transient ischemic attack
Cardiovascular accident
PRIOR CONCURRENT THERAPY:
Recovered from prior therapy
At least 28 days since prior major surgery
Prior therapy for advanced disease allowed
No prior oxaliplatin-based therapy
Concurrent maintenance and palliative treatment during study chemotherapy allowed (e.g., nutritional or transfusional support or pain control)
No concurrent corticosteroids except when used under the following circumstances:
As oxaliplatin premedication
Anti-5-HT_3 as antiemetic
No concurrent cold cap or iced mouth rinses
No other concurrent chemotherapy
No placement of hepatic artery port for regional chemotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijay Khatri, MD, FACS
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Oxaliplatin, Capecitabine, and Bevacizumab Followed By Surgery and/or Radiofrequency Ablation in Patients With Colorectal Cancer
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