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

Phase 2

Withdrawn

• Conditions: Colorectal Carcinoma; Liver Metastases

• Registration Number: NCT00735241
• Lead Sponsor: Sirtex Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Toxicity and safety	from study entry until 28 days after last cycle of chemotherapy

Trial Locations

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