Efficacy of Neoadjuvant XELOX/AVASTIN Therapy for Nonresectable Colorectal Liver Metastases With Secondary Hepatic Resection/Radiofrequency
18 Years
N/A
Both
Colorectal Cancer, Metastatic Cancer
Trial Information
Efficacy of Neoadjuvant XELOX/AVASTIN Therapy for Nonresectable Colorectal Liver Metastases With Secondary Hepatic Resection/Radiofrequency
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Conversion rate of nonresectable disease to resectable disease
Safety Issue:
No
Principal Investigator
Vijay Khatri, MD, FACS
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Davis
Authority:
Unspecified
Study ID:
CDR0000517440
NCT ID:
NCT00408772
Start Date:
June 2007
Completion Date:
Related Keywords:
- Colorectal Cancer
- Metastatic Cancer
- liver metastases
- stage IV colon cancer
- stage IV rectal cancer
- adenocarcinoma of the colon
- adenocarcinoma of the rectum
- recurrent colon cancer
- recurrent rectal cancer
- Colorectal Neoplasms
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| University of California Davis Cancer Center | Sacramento, California 95817 |
