Status:
WITHDRAWN
Oxaliplatin, Capecitabine, and Bevacizumab Followed By Surgery and/or Radiofrequency Ablation in Patients With Colorectal Cancer
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Sanofi
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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. Mo...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00408772
Start Date
June 1 2007
End Date
April 1 2008
Last Update
June 9 2017
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817