FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma

Study Overview
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Brief Summary
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This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as chemo-SIRT), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.

Official Title
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Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

Conditions
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Colorectal Carcinoma, Liver Metastases

Intervention / Treatment
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* Device: SIR-Spheres microspheres
* Drug: FOLFOX6 cycles 1-3
* Drug: FOLFOX6 cycles 4 onwards
* Drug: Bevacizumab cycles 3 onwards


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma of the colon or rectum. Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent. ECOG performance status 0 - 1. Adequate hematological, renal and hepatic function. Exclusion Criteria: Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment. Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed. Previous radiotherapy delivered to the upper abdomen. Peripheral neuropathy > grade 1 (NCI-CTCv3).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SIR-Spheres microspheres|SIR-Spheres yttrium-90 microspheres|
|Drug: FOLFOX6 cycles 1-3|Oxaliplatin 60 mg/m2, IV infusion, q 2 weeks Leucovorin 200 mg/m2, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks|
|Drug: FOLFOX6 cycles 4 onwards|Oxaliplatin 85 mg/m2 given, IV infusion, q 2 weeks Leucovorin 200 mg/m2 given, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks|
|Drug: Bevacizumab cycles 3 onwards|Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity and safety |  | from study entry until 28 days after last cycle of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, colorectal cancer, liver metastases, SIR-Spheres Microspheres, yttrium-90, FOLFOX, Bevacizumab, chemo-radiation