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

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: Colorectal Carcinoma, Liver Metastases

In brief

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.

Key facts

Study ID

NCT00735241

Run by

Sirtex Medical

People needed

0

Starts

2008-07-01

Expected to finish

2009-03-01

Last updated by the study team

2015-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Sacred Heart Medical Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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