Clinical trial NCT00972036: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colon Cancer
Rectal Cancer
Keywords: COLON
LIVER
RECTUM
SIR-Spheres
09-030
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Sirtex Medical
First posted: 2009-09-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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).
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center 1275 York Avenue
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Constantinos Sofocleous, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: