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

Sirtex Medical

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Colorectal Carcinoma Liver Metastases

Interventions

SIR-Spheres microspheresDEVICE

SIR-Spheres yttrium-90 microspheres

FOLFOX6 cycles 1-3DRUG

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

FOLFOX6 cycles 4 onwardsDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (3)

William Beaumont Hospital

Royal Oak, Michigan, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Sacred Heart Medical Center

Spokane, Washington, United States

Outcomes

Primary Outcomes

Toxicity and safety

Time frame: from study entry until 28 days after last cycle of chemotherapy

Data from ClinicalTrials.gov

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