Colorectal Carcinoma, Liver Metastases
Conditions
Keywords
colon cancer, colorectal cancer, liver metastases, SIR-Spheres Microspheres, yttrium-90, FOLFOX, Bevacizumab, chemo-radiation
Brief summary
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.
Interventions
DEVICESIR-Spheres microspheres
SIR-Spheres yttrium-90 microspheres
DRUGFOLFOX6 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
DRUGFOLFOX6 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
DRUGBevacizumab cycles 3 onwards
Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy
Sponsors
Sirtex Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity and safety | from study entry until 28 days after last cycle of chemotherapy |
Countries
United States
Outcome results
None listed