Selective Internal Radiation Therapy (SIRT) in Patients With Unresectable Colorectal Cancer Liver Metastases Who Failed Prior Intraarterial Pump Chemotherapy

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00972036

Collaborator

Sirtex Medical (Industry)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Rectal Cancer	Device: SIR-spheres® (Selective Internal Radiation Therapy)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Unresectable colon cancer patients with liver metastases 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.	Device: SIR-spheres® (Selective Internal Radiation Therapy) 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.

Arm

Intervention/Treatment

Experimental: Unresectable colon cancer patients with liver metastases

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.

Device: SIR-spheres® (Selective Internal Radiation Therapy)

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.

Outcome Measures

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). [2 years]

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. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.