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

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972036
• Other study ID #: 09-030
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2009
• Last updated: December 10, 2014
• Start date: August 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms
• Rectal Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center 1275 York Avenue	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Sirtex Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center