Back to resultsSelective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy
Primary Purpose
Colon Cancer, Rectal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SIR-spheres® (Selective Internal Radiation Therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer focused on measuring COLON, LIVER, RECTUM, SIR-Spheres, 09-030
Eligibility Criteria
Inclusion Criteria:
- Histologic confirmation of colorectal cancer.
- Unequivocal imaging of hepatic metastases.
- Dominant Liver metastases. (Small amount extrahepatic disease allowed.)
- Unresectable liver metastases.
- Liver Metastases non-eligible for, or progressed after ablation
- Failed prior HAC.
- ECOG performance status 0 - 1
- WBC > or = to 1.5 x 109/L
- Platelets > or = to 50 x 109/L
- Creatinine ≤ 1.5 mg/dl
- Bilirubin ≤ 1.5 mg/dl
- Age > or = to 18 years
- Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active, must agree to use an acceptable method of contraception.
- Male patients must be surgically sterile, or if sexually active, must agree to use an acceptable method of contraception.
- Life expectancy of at least 3 months without any active treatment.
- No chemotherapy regimen administration for at least 4 weeks prior to SIRT administration
Exclusion Criteria:
- Evidence of severe cirrhosis (CHILDS B and C), portal hypertension with gastroesophageal varices and liver failure as determined by clinical, radiologic or laboratory assessment.
- Previous radiotherapy delivered to the liver.
- Pregnant or breast-feeding.
Any of the following are contraindications to the use of Yttrium-90 microspheres, and are therefore exclusion criteria:
- With a Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy that shows any disposition to the gastrointestinal tract that cannot be corrected by angiographic and embolization techniques.
- With more than 20% shunting of blood to the lungs as estimated in the Lung Scintigram performed after the intraarterial injection of Tc MAA. Radiation pneumonitis has been seen in patients receiving doses of Yttrium-90 greater than 30 Gy in a single treatment. This corresponds to the shunt over 20% presence of vascular abnormalities, bleeding diathesis, making catheterization of the hepatic artery contraindication.
Sites / Locations
- Memorial Sloan-Kettering Cancer Center 1275 York Avenue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Unresectable colon cancer patients with liver metastases
Arm Description
This study will be performed to evaluate the safety of Selective Internal Radiation Therapy (SIRT) in patients with liver only colorectal cancer metastases that have received hepatic arterial infusion pump and have progressed through at least one line of chemotherapy.
Outcomes
Primary Outcome Measures
To determine the safety, toxicity, and maximum tolerated dose of SIR-Spheres® in patients with unresectable metastatic colorectal cancer to the liver (CLM) who have received previous hepatic arterial infusion chemotherapy (HAC).
Secondary Outcome Measures
To obtain preliminary evidence of any clinical efficacy of the SIRT therapy in these heavily pretreated patients with unresectable CLM who have received hepatic arterial infusion pump and have failed at least one line of prior chemotherapy.
Full Information
NCT ID
NCT00972036
First Posted
September 3, 2009
Last Updated
December 10, 2014
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Sirtex Medical
1. Study Identification
Unique Protocol Identification Number
NCT00972036
Brief Title
Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy
Official Title
Phase I Study of Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Sirtex Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done with a new therapy called "Selective Internal Radiation Therapy" (known as SIRT). Radiation is an effective treatment for destroying tumors. It is widely used in cancer treatment. However, radiation can harm normal tissue. SIR-Spheres are tiny plastic beads. They contain a radioactive agent called Yttrium-90. These beads can be delivered through a small tube inserted into the blood vessel that goes directly to the tumor. The radiation goes directly to the tumor. This spares healthy parts of your liver.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer
Keywords
COLON, LIVER, RECTUM, SIR-Spheres, 09-030
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unresectable colon cancer patients with liver metastases
Arm Type
Experimental
Arm Description
This study will be performed to evaluate the safety of Selective Internal Radiation Therapy (SIRT) in patients with liver only colorectal cancer metastases that have received hepatic arterial infusion pump and have progressed through at least one line of chemotherapy.
Intervention Type
Device
Intervention Name(s)
SIR-spheres® (Selective Internal Radiation Therapy)
Intervention Description
SIR-spheres® will be administered at 70%, 85% and 100% of the calculated individual patient dose (approximately 1 month prior to SIR-spheres® administration).The first cohort will receive SIRSpheres® at 70% of the individually calculated patient dose, the second will receive 85% of the calculated patient dose, and the third will receive 100% of the calculated patient dose.
Primary Outcome Measure Information:
Title
To determine the safety, toxicity, and maximum tolerated dose of SIR-Spheres® in patients with unresectable metastatic colorectal cancer to the liver (CLM) who have received previous hepatic arterial infusion chemotherapy (HAC).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
To obtain preliminary evidence of any clinical efficacy of the SIRT therapy in these heavily pretreated patients with unresectable CLM who have received hepatic arterial infusion pump and have failed at least one line of prior chemotherapy.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic confirmation of colorectal cancer.
Unequivocal imaging of hepatic metastases.
Dominant Liver metastases. (Small amount extrahepatic disease allowed.)
Unresectable liver metastases.
Liver Metastases non-eligible for, or progressed after ablation
Failed prior HAC.
ECOG performance status 0 - 1
WBC > or = to 1.5 x 109/L
Platelets > or = to 50 x 109/L
Creatinine ≤ 1.5 mg/dl
Bilirubin ≤ 1.5 mg/dl
Age > or = to 18 years
Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active, must agree to use an acceptable method of contraception.
Male patients must be surgically sterile, or if sexually active, must agree to use an acceptable method of contraception.
Life expectancy of at least 3 months without any active treatment.
No chemotherapy regimen administration for at least 4 weeks prior to SIRT administration
Exclusion Criteria:
Evidence of severe cirrhosis (CHILDS B and C), portal hypertension with gastroesophageal varices and liver failure as determined by clinical, radiologic or laboratory assessment.
Previous radiotherapy delivered to the liver.
Pregnant or breast-feeding.
Any of the following are contraindications to the use of Yttrium-90 microspheres, and are therefore exclusion criteria:
With a Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy that shows any disposition to the gastrointestinal tract that cannot be corrected by angiographic and embolization techniques.
With more than 20% shunting of blood to the lungs as estimated in the Lung Scintigram performed after the intraarterial injection of Tc MAA. Radiation pneumonitis has been seen in patients receiving doses of Yttrium-90 greater than 30 Gy in a single treatment. This corresponds to the shunt over 20% presence of vascular abnormalities, bleeding diathesis, making catheterization of the hepatic artery contraindication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantinos Sofocleous, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center 1275 York Avenue
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy
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