Colon Cancer, Rectal Cancer
Conditions
Keywords
COLON, LIVER, RECTUM, SIR-Spheres, 09-030
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.
Interventions
DEVICESIR-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.
Sponsors
Sirtex Medical
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed