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

Sirtex Medical

Status and phase

Withdrawn

Phase 3

Phase 2

Conditions

Colorectal Carcinoma

Liver Metastases

Treatments

Drug: Bevacizumab cycles 3 onwards

Device: SIR-Spheres microspheres

Drug: FOLFOX6 cycles 4 onwards

Drug: FOLFOX6 cycles 1-3

Study type

Interventional

Funder types

Industry

Identifiers

NCT00735241

STX0207

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).