Pre- and Post-operative FOLFOX Based Therapy for Patients With Colorectal Cancer With Liver Involvement
NCT ID: NCT00537823
Last Updated: 2016-12-20
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
9 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-06-30
Study Completion Date
2011-07-31
Brief Summary
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The purpose of this study is to determine the effect of short-duration pre-operative FOLFOX based therapy on postoperative problems after liver surgery for patients with metastatic colorectal cancer.
Detailed Description
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Although early stage, localized colon and rectal cancers are associated with 5 year survival rates of nearly 90%, only a minority of patients present with localized disease. Unfortunately, at the time of their initial presentation, approximately 35% of patients with colon or rectal cancer have metastatic disease. Nearly two thirds of these patients with stage IV disease have evidence of extrahepatic spread and have a median overall survival rate of 8-10 months in the absence of further treatment. Even with the most intensive chemotherapeutic regimens, the median overall survival for these patients ranges from 12 months to 20 months. However, a small subset of patients with stage IV disease has isolated hepatic metastatic disease and can undergo resection. The patients with completely resected liver metastases enjoy a significantly higher overall five-year survival, which is as high as 58% in carefully selected patients. Ten-year overall survival has been reported in 22% of patients. Despite this improvement, the five-year disease-free survival for these patients is at best 35%, with hepatic recurrences occurring in 46%.
The fact that adjuvant chemotherapy improves the three-year survival rate for stage II disease and five-year survival rates for stage III disease implies that it can treat micrometastatic disease in some fraction of patients. Because micrometastatic disease is likely the cause of the high recurrence rate in patients who undergo liver resection, there is a clear biologic rationale for using postoperative adjuvant chemotherapy after liver resection. Although this strategy is a common practice in many centers, no convincing data that this improves survival have been reported. A large randomized phase III trial (EORTC 40983) examining this question is currently ongoing and effect on survival has not yet been reported. Given that systemic chemotherapy after liver resection remains of unproven benefit at the present time, many have wondered if preoperative treatment might have more promise in improving recurrence rates.
The fact that adjuvant chemotherapy improves the three-year survival rate for stage II disease and five-year survival rates for stage III disease implies that it can treat micrometastatic disease in some fraction of patients. Because micrometastatic disease is likely the cause of the high recurrence rate in patients who undergo liver resection, there is a clear biologic rationale for using postoperative adjuvant chemotherapy after liver resection. Although this strategy is a common practice in many centers, no convincing data that this improves survival have been reported. A large randomized phase III trial (EORTC 40983) examining this question is currently ongoing and effect on survival has not yet been reported. Given that systemic chemotherapy after liver resection remains of unproven benefit at the present time, many have wondered if preoperative treatment might have more promise in improving recurrence rates.
Conditions
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Colorectal Cancer
Metastases
Keywords
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Colorectal Cancer
Metastasis
Neoadjuvant Therapy
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Arm 1 - Wildtype
Neoadjuvant therapy
Week 1
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8 \*Cetuximab 250 mg/m\^2 IV weekly
Weeks 3, 5, 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Week 1, 3, 5, 7, 9, 11, 13, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV Cetuximab 400 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2/day over 46 hours
Weeks 2, 4, 6, 8, 10, 12, 16
\*Cetuximab 250 mg/m\^2 IV weekly
Group Type
EXPERIMENTAL
Cetuximab
Intervention Type
DRUG
Leucovorin
Intervention Type
DRUG
Oxaliplatin
Intervention Type
DRUG
Fluorouracil
Intervention Type
DRUG
Arm 2 K-Ras 12/13 codon mutation
Neoadjuvant Therapy
Weeks 1, 3, 5
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Wait 3-8 weeks after completion of therapy
Liver resection
Wait 4 weeks or until clinical status allows
Adjuvant Therapy
Weeks 1, 3, 5, 9, 11, 13
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* Bevacizumab 5 mg/kg IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Week 7, 15
* Leucovorin 400 mg/m\^2 IV
* Oxaliplatin 85 mg/m\^2 IV
* 5FU bolus 400 mg/m\^2
* 5FU CIVI 1200 mg/m\^2
Group Type
EXPERIMENTAL
Bevacizumab
Intervention Type
DRUG
Leucovorin
Intervention Type
DRUG
Oxaliplatin
Intervention Type
DRUG
Fluorouracil
Intervention Type
DRUG
Interventions
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Cetuximab
Intervention Type
DRUG
Bevacizumab
Intervention Type
DRUG
Leucovorin
Intervention Type
DRUG
Oxaliplatin
Intervention Type
DRUG
Fluorouracil
Intervention Type
DRUG
Other Intervention Names
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Erbitux
Avastin
Eligibility Criteria
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Inclusion Criteria
* Synchronous or metachronous colorectal metastases
* Technically resectable liver metastases
* Four or fewer metastases
* No tumors in porta hepatis
* Resection of no more than 70% of liver needed
* Medically suitable candidate for major liver resection
* FDG-PET scan without metastatic disease outside the liver
* Technically resectable liver metastases
* Four or fewer metastases
* No tumors in porta hepatis
* Resection of no more than 70% of liver needed
* Medically suitable candidate for major liver resection
* FDG-PET scan without metastatic disease outside the liver
Exclusion Criteria
* Near-obstructing or obstructing colon lesions in patients in whom combined resection is planned (as delay for preoperative chemotherapy would be medially impossible)
* Treatment with FOLFOX or cetuximab within 12 months
* Treatment with irinotecan within 12 months
* Abnormal liver function (ALT or AST \> 5x ULN, bilirubin \> 3x ULN)
* Body mass index \>/= 35 kg/m² (as the risk for steatohepatitis is increased)
* Renal insufficiency (Cr \> 2.5mg/dL)
* Interstitial lung disease (because cetuximab has been rarely associated with development of interstitial lung disease)
* ECOG performance score \>/= 3
* Patients unable to give informed consent
* Pregnant patient (as cetuximab is a Class C drug)
* Peripheral neuropathy \>/= grade II (as oxaliplatin causes neuropathy to worsen)
* Treatment with FOLFOX or cetuximab within 12 months
* Treatment with irinotecan within 12 months
* Abnormal liver function (ALT or AST \> 5x ULN, bilirubin \> 3x ULN)
* Body mass index \>/= 35 kg/m² (as the risk for steatohepatitis is increased)
* Renal insufficiency (Cr \> 2.5mg/dL)
* Interstitial lung disease (because cetuximab has been rarely associated with development of interstitial lung disease)
* ECOG performance score \>/= 3
* Patients unable to give informed consent
* Pregnant patient (as cetuximab is a Class C drug)
* Peripheral neuropathy \>/= grade II (as oxaliplatin causes neuropathy to worsen)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Washington University School of Medicine
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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David Linehan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Site Status
Countries
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United States
References
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Related Links
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http://www.siteman.wustl.edu
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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07-0182
Identifier Type: -
Identifier Source: org_study_id