Back to resultsFOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma (FAST)
Primary Purpose
Colorectal Carcinoma, Liver Metastases
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SIR-Spheres microspheres
FOLFOX6 cycles 1-3
FOLFOX6 cycles 4 onwards
Bevacizumab cycles 3 onwards
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma focused on measuring colon cancer, colorectal cancer, liver metastases, SIR-Spheres Microspheres, yttrium-90, FOLFOX, Bevacizumab, chemo-radiation
Eligibility Criteria
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).
Sites / Locations
- William Beaumont Hospital
- Carolinas Medical Center
- Sacred Heart Medical Center
Outcomes
Primary Outcome Measures
Toxicity and safety
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00735241
Brief Title
FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma
Acronym
FAST
Official Title
Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn by the study sponsor.
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
March 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sirtex Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma, Liver Metastases
Keywords
colon cancer, colorectal cancer, liver metastases, SIR-Spheres Microspheres, yttrium-90, FOLFOX, Bevacizumab, chemo-radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
SIR-Spheres microspheres
Intervention Description
SIR-Spheres yttrium-90 microspheres
Intervention Type
Drug
Intervention Name(s)
FOLFOX6 cycles 1-3
Other Intervention Name(s)
Eloxatin, Folinic acid, 5-FU
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
FOLFOX6 cycles 4 onwards
Other Intervention Name(s)
Eloxatin, Folinic acid, 5-FU
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bevacizumab cycles 3 onwards
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy
Primary Outcome Measure Information:
Title
Toxicity and safety
Time Frame
from study entry until 28 days after last cycle of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Carter, MD
Organizational Affiliation
Rocky Mountain Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlie Nutting, DO
Organizational Affiliation
Skye Ridge Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma
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